Trial Outcomes & Findings for Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis (NCT NCT01786668)
NCT ID: NCT01786668
Last Updated: 2016-06-10
Results Overview
The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
208 participants
Primary outcome timeframe
Week 12
Results posted on
2016-06-10
Participant Flow
In total 208 participants were randomized to double-blind treatment; 52 to each treatment group (tofacitinib 2 milligrams \[mg\] twice daily \[BID\], tofacitinib 5 mg BID, tofacitinib 10 mg BID, and placebo BID). One participant was randomized to the placebo group but did not receive study drug, as such only 207 participants received study treatment.
Participant milestones
| Measure |
Tofacitinib 2 mg BID
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning \[AM\] and afternoon \[PM\]) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
52
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
5
|
4
|
Reasons for withdrawal
| Measure |
Tofacitinib 2 mg BID
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning \[AM\] and afternoon \[PM\]) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
Baseline characteristics by cohort
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Age
|
41.8 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
41.2 Years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
41.6 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
41.9 Years
STANDARD_DEVIATION 12.9 • n=4 Participants
|
41.6 Years
STANDARD_DEVIATION 11.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized study drug (Tofacitinib or placebo).
The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12
|
56.0 Percentage of participants
|
63.0 Percentage of participants
|
67.4 Percentage of participants
|
40.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: FAS
The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving ASAS20 at Week 12
|
51.92 Percentage of participants
|
80.77 Percentage of participants
|
55.77 Percentage of participants
|
41.18 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8Population: FAS - n=number of responders at each visit.
Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8
Week 2 (n=21,17,18,14)
|
40.38 Percentage of participants
|
32.69 Percentage of participants
|
34.62 Percentage of participants
|
27.45 Percentage of participants
|
|
Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8
Week 4 (n=25,29,25,17)
|
48.08 Percentage of participants
|
55.77 Percentage of participants
|
48.08 Percentage of participants
|
33.33 Percentage of participants
|
|
Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8
Week 8 (n=30, 37, 28, 22)
|
57.69 Percentage of participants
|
71.15 Percentage of participants
|
53.85 Percentage of participants
|
43.14 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=42 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=44 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=44 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=34 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12
|
-1.70 Units on a scale
Standard Error 0.779
|
-3.15 Units on a scale
Standard Error 0.788
|
-3.55 Units on a scale
Standard Error 0.795
|
-0.81 Units on a scale
Standard Error 0.806
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=41 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=44 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=44 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=34 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12
|
-3.09 Units on a scale
Standard Error 1.061
|
-5.51 Units on a scale
Standard Error 1.063
|
-6.57 Units on a scale
Standard Error 1.073
|
-0.09 Units on a scale
Standard Error 1.085
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=41 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=44 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=44 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=34 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12
|
-1.05 Units on a scale
Standard Error 0.364
|
-2.22 Units on a scale
Standard Error 0.364
|
-2.13 Units on a scale
Standard Error 0.368
|
-0.41 Units on a scale
Standard Error 0.372
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - n=number of responders at each visit.
ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12
Week 12 (n=22, 24, 20, 10)
|
42.31 Percentage of participants
|
46.15 Percentage of participants
|
38.46 Percentage of participants
|
19.61 Percentage of participants
|
|
Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12
Week 2 (n=7, 7, 9, 8)
|
13.46 Percentage of participants
|
13.46 Percentage of participants
|
17.31 Percentage of participants
|
15.69 Percentage of participants
|
|
Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12
Week 4 (n=15, 17, 11, 8)
|
28.85 Percentage of participants
|
32.69 Percentage of participants
|
21.15 Percentage of participants
|
15.69 Percentage of participants
|
|
Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12
Week 8 (n=15, 18, 19, 14)
|
28.85 Percentage of participants
|
34.62 Percentage of participants
|
36.54 Percentage of participants
|
27.45 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - n=number of responders at each visit
ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12
Week 2 (n=12, 7, 11, 4)
|
23.08 Percentage of participants
|
13.46 Percentage of participants
|
21.15 Percentage of participants
|
7.84 Percentage of participants
|
|
Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12
Week 4 (n=10, 16, 15, 4)
|
19.23 Percentage of participants
|
30.77 Percentage of participants
|
28.85 Percentage of participants
|
7.84 Percentage of participants
|
|
Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12
Week 8 (n=11, 22, 15, 5)
|
21.15 Percentage of participants
|
42.31 Percentage of participants
|
28.85 Percentage of participants
|
9.80 Percentage of participants
|
|
Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12
Week 12 (n=10, 26, 20, 8)
|
19.23 Percentage of participants
|
50.00 Percentage of participants
|
38.46 Percentage of participants
|
15.69 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=51 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=51 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=50 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12
Week 2
|
-0.68 Units on a scale
Standard Error 0.096 • Interval 15.2 to 39.7
|
-1.00 Units on a scale
Standard Error 0.096
|
-0.97 Units on a scale
Standard Error 0.096
|
-0.50 Units on a scale
Standard Error 0.097
|
|
Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12
Week 4
|
-1.01 Units on a scale
Standard Error 0.099
|
-1.20 Units on a scale
Standard Error 0.099
|
-1.17 Units on a scale
Standard Error 0.099
|
-0.58 Units on a scale
Standard Error 0.100
|
|
Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12
Week 8
|
-1.08 Units on a scale
Standard Error 0.111
|
-1.36 Units on a scale
Standard Error 0.111
|
-1.32 Units on a scale
Standard Error 0.112
|
-0.73 Units on a scale
Standard Error 0.112
|
|
Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12
Week 12
|
-1.23 Units on a scale
Standard Error 0.119
|
-1.41 Units on a scale
Standard Error 0.119
|
-1.37 Units on a scale
Standard Error 0.121
|
-0.68 Units on a scale
Standard Error 0.123
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - n=number of responders at each visit
The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12
Week 2 (n=14, 25, 21, 8)
|
26.92 Percentage of participants
|
48.08 Percentage of participants
|
40.38 Percentage of participants
|
15.69 Percentage of participants
|
|
Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12
Week4 (n=22, 30, 27, 10)
|
42.31 Percentage of participants
|
57.69 Percentage of participants
|
51.92 Percentage of participants
|
19.61 Percentage of participants
|
|
Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12
Week 8 (n=23, 31, 31, 15)
|
44.23 Percentage of participants
|
59.62 Percentage of participants
|
59.62 Percentage of participants
|
29.41 Percentage of participants
|
|
Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12
Week 12 (n=27, 33, 29, 14)
|
51.92 Percentage of participants
|
63.46 Percentage of participants
|
55.77 Percentage of participants
|
27.45 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - n=number of responders at each visit
The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12
Week 2 (n=4, 4, 4, 1)
|
7.69 Percentage of participants
|
7.69 Percentage of participants
|
7.69 Percentage of participants
|
1.96 Percentage of participants
|
|
Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12
Week 4 (n=6, 6, 8, 3)
|
11.54 Percentage of participants
|
11.54 Percentage of participants
|
15.38 Percentage of participants
|
5.88 Percentage of participants
|
|
Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12
Week 8 (n=6, 14, 12, 5)
|
11.54 Percentage of participants
|
26.92 Percentage of participants
|
23.08 Percentage of participants
|
9.80 Percentage of participants
|
|
Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12
Week 12 (n=10, 12, 13, 6)
|
19.23 Percentage of participants
|
23.08 Percentage of participants
|
25.00 Percentage of participants
|
11.76 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - n=number of responders at each visit
The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS \<1.3 units. Missing data were handled by NRI/LOCF.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12
Week 8 (n=3, 1, 5, 1)
|
5.77 Percentage of participants
|
1.92 Percentage of participants
|
9.62 Percentage of participants
|
1.96 Percentage of participants
|
|
Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12
Week 2 (n=1, 1, 1, 0)
|
1.92 Percentage of participants
|
1.92 Percentage of participants
|
1.92 Percentage of participants
|
0.00 Percentage of participants
|
|
Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12
Week 4 (n=1, 3, 4, 1)
|
1.92 Percentage of participants
|
5.77 Percentage of participants
|
7.69 Percentage of participants
|
1.96 Percentage of participants
|
|
Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12
Week 12 (n=7, 7, 8, 4)
|
13.46 Percentage of participants
|
13.46 Percentage of participants
|
15.38 Percentage of participants
|
7.84 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+\[Q5+Q6/2\]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=51 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12
Week 2
|
-1.45 Units on a scale
Standard Error 0.219
|
-1.53 Units on a scale
Standard Error 0.217
|
-1.24 Units on a scale
Standard Error 0.219
|
-1.42 Units on a scale
Standard Error 0.219
|
|
Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12
Week 4
|
-1.90 Units on a scale
Standard Error 0.242
|
-1.93 Units on a scale
Standard Error 0.240
|
-1.84 Units on a scale
Standard Error 0.242
|
-1.60 Units on a scale
Standard Error 0.243
|
|
Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12
Week 8
|
-2.16 Units on a scale
Standard Error 0.268
|
-2.39 Units on a scale
Standard Error 0.267
|
-2.35 Units on a scale
Standard Error 0.271
|
-1.87 Units on a scale
Standard Error 0.271
|
|
Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12
Week 12
|
-2.75 Units on a scale
Standard Error 0.277
|
-2.88 Units on a scale
Standard Error 0.276
|
-2.68 Units on a scale
Standard Error 0.281
|
-1.85 Units on a scale
Standard Error 0.283
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - n=number of responders at each visit
BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12
Week 4 (n=15, 12, 15, 11)
|
28.85 Percentage of participants
|
23.08 Percentage of participants
|
28.85 Percentage of participants
|
21.57 Percentage of participants
|
|
Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12
Week 8 (n=18, 17, 21, 14)
|
34.62 Percentage of participants
|
32.69 Percentage of participants
|
40.38 Percentage of participants
|
27.45 Percentage of participants
|
|
Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12
Week 2 (n=6, 11, 7, 8)
|
11.54 Percentage of participants
Interval 2.92 to 20.61
|
21.15 Percentage of participants
|
13.46 Percentage of participants
|
15.69 Percentage of participants
|
|
Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12
Week 12 (n=24, 22, 22, 12)
|
46.15 Percentage of participants
|
42.31 Percentage of participants
|
42.31 Percentage of participants
|
23.53 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=51 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12
Week 2
|
-1.12 Units on a scale
Standard Error 0.192
|
-1.16 Units on a scale
Standard Error 0.191
|
-0.86 Units on a scale
Standard Error 0.192
|
-0.74 Units on a scale
Standard Error 0.192
|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12
Week 4
|
-1.36 Units on a scale
Standard Error 0.210
|
-1.61 Units on a scale
Standard Error 0.208
|
-1.32 Units on a scale
Standard Error 0.210
|
-1.02 Units on a scale
Standard Error 0.210
|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12
Week 8
|
-1.61 Units on a scale
Standard Error 0.247
|
-2.07 Units on a scale
Standard Error 0.246
|
-1.72 Units on a scale
Standard Error 0.249
|
-1.38 Units on a scale
Standard Error 0.249
|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12
Week 12
|
-1.90 Units on a scale
Standard Error 0.261
|
-2.39 Units on a scale
Standard Error 0.260
|
-2.24 Units on a scale
Standard Error 0.264
|
-1.43 Units on a scale
Standard Error 0.266
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=51 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=51 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12
Week 2
|
-0.09 Units on a scale
Standard Error 0.075
|
-0.24 Units on a scale
Standard Error 0.075
|
-0.22 Units on a scale
Standard Error 0.075
|
-0.09 Units on a scale
Standard Error 0.075
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12
Week 4
|
-0.15 Units on a scale
Standard Error 0.083
|
-0.24 Units on a scale
Standard Error 0.083
|
-0.26 Units on a scale
Standard Error 0.084
|
-0.14 Units on a scale
Standard Error 0.084
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12
Week 8
|
-0.34 Units on a scale
Standard Error 0.095
|
-0.40 Units on a scale
Standard Error 0.095
|
-0.48 Units on a scale
Standard Error 0.096
|
-0.19 Units on a scale
Standard Error 0.096
|
|
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12
Week 12
|
-0.33 Units on a scale
Standard Error 0.109
|
-0.42 Units on a scale
Standard Error 0.109
|
-0.55 Units on a scale
Standard Error 0.111
|
-0.16 Units on a scale
Standard Error 0.112
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=51 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=50 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=50 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12
Week 4
|
-0.16 Units on a scale
Standard Error 0.272
|
-0.93 Units on a scale
Standard Error 0.271
|
-0.89 Units on a scale
Standard Error 0.274
|
-0.11 Units on a scale
Standard Error 0.275
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12
Week 8
|
-0.79 Units on a scale
Standard Error 0.289
|
-1.19 Units on a scale
Standard Error 0.289
|
-0.97 Units on a scale
Standard Error 0.295
|
-0.54 Units on a scale
Standard Error 0.292
|
|
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12
Week 12
|
-0.66 Units on a scale
Standard Error 0.259
|
-1.37 Units on a scale
Standard Error 0.259
|
-1.24 Units on a scale
Standard Error 0.263
|
-0.34 Units on a scale
Standard Error 0.265
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Follow-upPopulation: FAS - n=number of participants completing the Specific Medical History Assessment at each visit.
Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE).
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=6 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=9 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=6 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=4 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Past But Not Active: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Currently Active: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Never: Week 12 (n=5, 6, 2, 3)
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Past But Not Active: Week 12 (n=5, 6, 2, 3)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Currently Active: Week 12 (n=5, 6, 2, 3)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Past But Not Active: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Never: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
28.6 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Past But Not Active: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: New Condition: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: New Condition: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Never: Week 8 (n=2, 6, 2, 4)
|
100 Percentage of Participants
|
83.3 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: New Condition: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Currently Active: Week 12 (n=5, 6, 2, 3)
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Past But Not Active: Week 4 (n=4, 7, 3, 2)
|
25.0 Percentage of Participants
|
28.6 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Currently Active: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Currenly Active: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Currently Active: Week 12 (n=5, 6, 2, 3)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Never: Follow-up (n=3, 6, 4, 2)
|
100 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Never: Baseline (n=6, 9, 6, 4)
|
100 Percentage of Participants
|
88.9 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Past But Not Active: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Currently Active: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
11.1 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: New Condition: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Never: Week 4 (n=4, 7, 3, 2)
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Past But Not Active: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Currently Active: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: New Condition: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Never: Week 8 (n=2, 6, 2, 4)
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: New Condition: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: New Condition: Week 12 (n=5, 6, 2, 3)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Never: Follow-up (n=3, 6, 4, 2)
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Past But Not Active: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: Currently Active: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
IBD: New Condition: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Never: Baseline (n=6, 9, 6, 4)
|
33.3 Percentage of Participants
|
44.4 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Past But Not Active: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: New Condition: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Never: Week 12 (n=5, 6, 2, 3)
|
40.0 Percentage of Participants
|
66.7 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Past But Not Active: Week 12 (n=5, 6, 2, 3)
|
60.0 Percentage of Participants
|
33.3 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: New Condition: Week 12 (n=5, 6, 2, 3)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Currently Active: Baseline (n=6, 9, 6, 4)
|
66.7 Percentage of Participants
|
44.4 Percentage of Participants
|
66.7 Percentage of Participants
|
75.0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: New condition: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
11.1 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Currently Active: Week 4 (n=4, 7, 3, 2)
|
100 Percentage of Participants
|
57.1 Percentage of Participants
|
66.7 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: New condition: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Never: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Past But Not Active: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Currently Active: Week 8 (n=2, 6, 2, 4)
|
100 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Never: Week 12 (n=5, 5, 2, 3)
|
20.0 Percentage of Participants
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Past But Not Active: Week 12 (n=5, 5, 2, 3)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Currently Active: Week 12 (n=5, 5, 2, 3)
|
40.0 Percentage of Participants
|
60.0 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: New Condition: Week 12 (n=5, 5, 2, 3)
|
40.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Never: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
50.0 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Past But Not Active: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: Currently Active: Follow-up (n=3, 6, 4, 2)
|
66.7 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PAI: New Condition: Follow-up (n=3, 6, 4, 2)
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Never: Baseline (n=6, 9, 6, 4)
|
100 Percentage of Participants
|
88.9 Percentage of Participants
|
83.3 Percentage of Participants
|
75.0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Past But Not Active: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Currently Active: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
11.1 Percentage of Participants
|
16.7 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: New Condition: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Never: Week 4 (n=4, 7, 3, 2)
|
100 Percentage of Participants
|
85.7 Percentage of Participants
|
66.7 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Past But Not Active: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Currently Active: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Past But Not Active: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Currently Active: Week 8 (n=2, 6, 2, 4)
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
50.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Never: Week 12 (n=5, 6, 2, 3)
|
80.0 Percentage of Participants
|
83.3 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Past But Not Active: Week 12 (n=5, 6, 2, 3)
|
20.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: New Condition: Week 12 (n=5, 6, 2, 3)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Never: Follow-up (n=3, 6, 4, 2)
|
100 Percentage of Participants
|
83.3 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Past But Not Active: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: Currently Active: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
PSO: New Condition: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Never: Baseline (n=6, 9, 6, 4)
|
50.0 Percentage of Participants
|
55.6 Percentage of Participants
|
83.3 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Past But Not Active: Baseline (n=6, 9, 6, 4)
|
16.7 Percentage of Participants
|
33.3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Currently Active: Baseline (n=6, 9, 6, 4)
|
33.3 Percentage of Participants
|
11.1 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: New Condition: Baseline (n=6, 9, 6, 4)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Past But Not Active: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
33.3 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Currently Active: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
16.7 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: New Condition: Follow-up (n=3, 6, 4, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
25.0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Never: Week 4 (n=4, 7, 3, 2)
|
75.0 Percentage of Participants
|
71.4 Percentage of Participants
|
66.7 Percentage of Participants
|
100 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: New Condition: Week 4 (n=4, 7, 3, 2)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History
UVE: Never: Week 8 (n=2, 6, 2, 4)
|
100 Percentage of Participants
|
50.0 Percentage of Participants
|
50.0 Percentage of Participants
|
100 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=51 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12
Week 2
|
-0.53 Swollen Joints
Standard Error 0.293
|
0.23 Swollen Joints
Standard Error 0.291
|
-1.20 Swollen Joints
Standard Error 0.292
|
-0.43 Swollen Joints
Standard Error 0.293
|
|
Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12
Week 4
|
-0.87 Swollen Joints
Standard Error 0.260
|
-0.57 Swollen Joints
Standard Error 0.259
|
-1.23 Swollen Joints
Standard Error 0.260
|
-0.86 Swollen Joints
Standard Error 0.261
|
|
Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12
Week 8
|
-1.02 Swollen Joints
Standard Error 0.442
|
-0.98 Swollen Joints
Standard Error 0.442
|
-1.28 Swollen Joints
Standard Error 0.451
|
-0.60 Swollen Joints
Standard Error 0.448
|
|
Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12
Week 12
|
-0.87 Swollen Joints
Standard Error 0.362
|
-0.79 Swollen Joints
Standard Error 0.362
|
-1.40 Swollen Joints
Standard Error 0.368
|
-0.99 Swollen Joints
Standard Error 0.373
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=51 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=51 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12
Week 2
|
0.30 cm
Standard Error 0.144
|
0.35 cm
Standard Error 0.143
|
-0.03 cm
Standard Error 0.144
|
0.24 cm
Standard Error 0.144
|
|
Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12
Week 4
|
0.54 cm
Standard Error 0.164
|
0.13 cm
Standard Error 0.162
|
0.13 cm
Standard Error 0.164
|
0.38 cm
Standard Error 0.165
|
|
Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12
Week 8
|
0.52 cm
Standard Error 0.178
|
0.35 cm
Standard Error 0.178
|
0.15 cm
Standard Error 0.182
|
0.13 cm
Standard Error 0.181
|
|
Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12
Week 12
|
0.69 cm
Standard Error 0.187
|
0.49 cm
Standard Error 0.187
|
0.13 cm
Standard Error 0.190
|
0.31 cm
Standard Error 0.193
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12
Week 12 Physical Health Score
|
6.34 Units on a scale
Standard Error 0.923
|
6.49 Units on a scale
Standard Error 0.914
|
7.05 Units on a scale
Standard Error 0.943
|
2.69 Units on a scale
Standard Error 0.932
|
|
Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12
Week 12 Mental Health Score
|
2.08 Units on a scale
Standard Error 1.306
|
4.15 Units on a scale
Standard Error 1.294
|
3.71 Units on a scale
Standard Error 1.336
|
2.41 Units on a scale
Standard Error 1.318
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state \[no problems\], 3=worst health state \[confined to bed\]).
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=52 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12
|
0.17 Units on a scale
Standard Error 0.034
|
0.16 Units on a scale
Standard Error 0.034
|
0.22 Units on a scale
Standard Error 0.035
|
0.10 Units on a scale
Standard Error 0.034
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12Population: FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Outcome measures
| Measure |
Tofacitinib 2 mg BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=51 Participants
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=51 Participants
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 Participants
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12
Week 8
|
4.54 Units on a scale
Standard Error 1.039
|
4.81 Units on a scale
Standard Error 1.039
|
4.19 Units on a scale
Standard Error 1.061
|
2.85 Units on a scale
Standard Error 1.053
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12
Week 12
|
4.74 Units on a scale
Standard Error 1.145
|
7.03 Units on a scale
Standard Error 1.145
|
7.58 Units on a scale
Standard Error 1.166
|
3.08 Units on a scale
Standard Error 1.178
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12
Week 2
|
3.62 Units on a scale
Standard Error 0.871
|
1.97 Units on a scale
Standard Error 0.871
|
2.17 Units on a scale
Standard Error 0.875
|
1.90 Units on a scale
Standard Error 0.872
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12
Week 4
|
4.25 Units on a scale
Standard Error 0.931
|
3.67 Units on a scale
Standard Error 0.927
|
2.80 Units on a scale
Standard Error 0.937
|
2.71 Units on a scale
Standard Error 0.938
|
Adverse Events
Tofacitinib 2 mg BID
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Tofacitinib 5 mg BID
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Tofacitinib 10 mg BID
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo BID
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tofacitinib 2 mg BID
n=52 participants at risk
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 participants at risk
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 participants at risk
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 participants at risk
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/18 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Uterine spasm
|
0.00%
0/18 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/18 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Tofacitinib 2 mg BID
n=52 participants at risk
Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 5 mg BID
n=52 participants at risk
Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
|
Tofacitinib 10 mg BID
n=52 participants at risk
Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
Placebo BID
n=51 participants at risk
Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
3/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.9%
2/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
4/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
7.7%
4/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.9%
3/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
4/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.8%
3/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/18 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.6%
1/18 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.9%
2/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/18 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/13 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.8%
2/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
2.0%
1/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
2.9%
1/34 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/39 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/38 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/32 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
1/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/52 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
3.9%
2/51 • From informed consent through and including 28 calendar days after the last administration of the investigational product.
The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60