Trial Outcomes & Findings for A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) (NCT NCT03845517)
NCT ID: NCT03845517
Last Updated: 2024-09-05
Results Overview
SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (\>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than \[\<\] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
350 participants
Primary outcome timeframe
Week 52
Results posted on
2024-09-05
Participant Flow
A total of 350 participants with active systemic lupus erythematosus (SLE) were enrolled and randomized in the study.
Participant milestones
| Measure |
Placebo
Participants were randomized to receive placebo matched to PF-06700841 once daily (QD) for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
Participants were randomized to receive PF-06700841 15 milligrams (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Treatment Period (52 Weeks)
STARTED
|
100
|
50
|
101
|
99
|
|
Treatment Period (52 Weeks)
COMPLETED
|
68
|
36
|
78
|
71
|
|
Treatment Period (52 Weeks)
NOT COMPLETED
|
32
|
14
|
23
|
28
|
|
Follow-up Period (4 Weeks)
STARTED
|
100
|
50
|
101
|
99
|
|
Follow-up Period (4 Weeks)
COMPLETED
|
89
|
42
|
89
|
92
|
|
Follow-up Period (4 Weeks)
NOT COMPLETED
|
11
|
8
|
12
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Participants were randomized to receive placebo matched to PF-06700841 once daily (QD) for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
Participants were randomized to receive PF-06700841 15 milligrams (mg) tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Treatment Period (52 Weeks)
Adverse Event
|
12
|
7
|
10
|
17
|
|
Treatment Period (52 Weeks)
Death
|
0
|
0
|
1
|
0
|
|
Treatment Period (52 Weeks)
Lack of Efficacy
|
8
|
1
|
3
|
4
|
|
Treatment Period (52 Weeks)
Lost to Follow-up
|
2
|
0
|
1
|
0
|
|
Treatment Period (52 Weeks)
Non-compliance with study drug
|
1
|
0
|
0
|
0
|
|
Treatment Period (52 Weeks)
Physician's decision
|
0
|
0
|
1
|
0
|
|
Treatment Period (52 Weeks)
Site Terminated by Sponsor
|
2
|
0
|
0
|
0
|
|
Treatment Period (52 Weeks)
Other
|
2
|
0
|
0
|
0
|
|
Treatment Period (52 Weeks)
Pregnancy
|
1
|
0
|
0
|
1
|
|
Treatment Period (52 Weeks)
Protocol Violation
|
0
|
0
|
1
|
1
|
|
Treatment Period (52 Weeks)
Withdrawal by Subject
|
4
|
6
|
6
|
5
|
|
Follow-up Period (4 Weeks)
Adverse Event
|
4
|
2
|
0
|
2
|
|
Follow-up Period (4 Weeks)
Death
|
0
|
0
|
1
|
1
|
|
Follow-up Period (4 Weeks)
Lost to Follow-up
|
2
|
1
|
2
|
0
|
|
Follow-up Period (4 Weeks)
Physician's decision
|
0
|
0
|
1
|
1
|
|
Follow-up Period (4 Weeks)
Study terminated by sponsor
|
0
|
0
|
0
|
1
|
|
Follow-up Period (4 Weeks)
Other
|
1
|
0
|
1
|
0
|
|
Follow-up Period (4 Weeks)
Pregnancy
|
1
|
0
|
0
|
0
|
|
Follow-up Period (4 Weeks)
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Follow-up Period (4 Weeks)
Withdrawal by Subject
|
3
|
5
|
7
|
1
|
Baseline Characteristics
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Baseline characteristics by cohort
| Measure |
Placebo
n=100 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 Years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
41.5 Years
STANDARD_DEVIATION 11.79 • n=7 Participants
|
42.8 Years
STANDARD_DEVIATION 12.71 • n=5 Participants
|
41.0 Years
STANDARD_DEVIATION 11.47 • n=4 Participants
|
42.0 Years
STANDARD_DEVIATION 11.37 • n=21 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
327 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
239 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: Full analysis set (FAS) included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants at Week 52 with Non-Responder Imputation (NRI) and Last Observation Carried Forward from Week 48 (LOCF48) applied.
SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (\>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than \[\<\] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
Outcome measures
| Measure |
Placebo
n=96 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=47 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=99 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=92 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52
|
64.6 Percentage of participants
Interval 54.5 to 74.7
|
57.4 Percentage of participants
Interval 42.2 to 72.6
|
69.7 Percentage of participants
Interval 60.1 to 79.3
|
66.3 Percentage of participants
Interval 56.1 to 76.5
|
SECONDARY outcome
Timeframe: Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants at Week 52 with NRI and LOCF48 applied.
BICLA included: BILAG-2004, SLEDAI-2K and PhGA. Participants were classified as responders, if they met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =\<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (\<10 percent \[%\] worsening) in analogue PhGA. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
Outcome measures
| Measure |
Placebo
n=96 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=47 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=99 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=92 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52
|
43.8 Percentage of participants
Interval 33.3 to 54.2
|
42.6 Percentage of participants
Interval 27.4 to 57.8
|
52.5 Percentage of participants
Interval 42.2 to 62.9
|
53.3 Percentage of participants
Interval 42.5 to 64.0
|
SECONDARY outcome
Timeframe: Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here "Number of Participants Analyzed" signifies participants at Week 52 with NRI applied.
LLDAS was defined as SLE disease activity index (SLEDAI-2k \<=4, with no activity in major organ systems \[renal, central nervous system, cardiopulmonary, vasculitis, fever\]) and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with the previous assessment; a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI PhGA (scale 0-3; higher scores = higher severity) \<=1; a current prednisolone (or equivalent) dose \<=7.5 milligram per day (mg/daily); and well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.
Outcome measures
| Measure |
Placebo
n=93 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=47 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=97 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=88 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52
|
22.6 Percentage of participants
Interval 13.5 to 31.6
|
21.3 Percentage of participants
Interval 8.5 to 34.0
|
35.1 Percentage of participants
Interval 25.0 to 45.1
|
34.1 Percentage of participants
Interval 23.6 to 44.6
|
SECONDARY outcome
Timeframe: Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosingPopulation: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline Prednisone or equivalent \>7.5 mg/day were analyzed. Here, "Number of Participants Analyzed" signifies participants at Week 52 with NRI applied.
In this outcome measure data is reported for participants who achieved a reduction in prednisone (or equivalent) dose to \<=7.5 mg/day and sustained for 12 Weeks prior at Week 52 and they also sustained this dose reduction for 12 weeks prior to Week 52 (Week 40 to Week 52).
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=33 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=46 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=43 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/Day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline
|
26.4 Percentage of participants
Interval 13.6 to 39.2
|
36.4 Percentage of participants
Interval 18.4 to 54.3
|
37.0 Percentage of participants
Interval 21.9 to 52.0
|
41.9 Percentage of participants
Interval 26.0 to 57.8
|
SECONDARY outcome
Timeframe: 12 Weeks prior at Week 52 (Week 40 to Week 52)Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline Prednisone or equivalent \>7.5 mg/day were analyzed. Here, "Number of Participants Analyzed" signifies participants at Week 52 with NRI applied.
In this outcome measure data is reported for participants who achieved a reduction in SRI-4 response with prednisone dose reduced to \<=7.5 mg/day and sustained for 12 weeks at Week 52.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=33 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=46 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=43 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/Day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline
|
20.8 Percentage of participants
Interval 8.9 to 32.6
|
30.3 Percentage of participants
Interval 13.1 to 47.5
|
32.6 Percentage of participants
Interval 18.0 to 47.2
|
32.6 Percentage of participants
Interval 17.4 to 47.7
|
SECONDARY outcome
Timeframe: Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Number of participants in FAS with baseline CLASI-A score \>= 10 were analyzed. Here, "Number of Participants Analyzed" signifies participants at Week 52 with NRI applied.
CLASI is an validated measurement instrument for lupus erythematosus developed for use in clinical studies that consists of separate scores for the activity of the disease (CLASI-A). The CLASI activity score is calculated on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI activity score ranges from 0-70, with higher scores indicating more severe skin disease. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70).
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=12 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=27 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=16 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10
|
73.9 Percentage of participants
Interval 53.8 to 94.0
|
58.3 Percentage of participants
Interval 26.3 to 90.4
|
77.8 Percentage of participants
Interval 60.2 to 95.3
|
56.3 Percentage of participants
Interval 28.8 to 83.7
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable with observed data at Week 52.
The FACIT-F Scale is a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=36 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=75 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=64 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52
|
4.6 Units on a scale
Interval 2.5 to 6.6
|
7.4 Units on a scale
Interval 4.5 to 10.2
|
5.8 Units on a scale
Interval 3.8 to 7.8
|
7.6 Units on a scale
Interval 5.5 to 9.7
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit.
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others; measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Physical health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=36 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=75 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=64 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52
|
11.585 Units on a scale
Interval 7.475 to 15.695
|
10.892 Units on a scale
Interval 5.241 to 16.544
|
12.371 Units on a scale
Interval 8.464 to 16.278
|
14.875 Units on a scale
Interval 10.748 to 19.002
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit.
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Emotional health domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=36 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=75 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=64 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52
|
8.113 Units on a scale
Interval 4.132 to 12.093
|
10.469 Units on a scale
Interval 4.968 to 15.969
|
7.547 Units on a scale
Interval 3.749 to 11.346
|
11.823 Units on a scale
Interval 7.806 to 15.84
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit.
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Body image domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Outcome measures
| Measure |
Placebo
n=62 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=32 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=66 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=50 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52
|
9.207 Units on a scale
Interval 4.352 to 14.062
|
10.935 Units on a scale
Interval 4.07 to 17.799
|
8.169 Units on a scale
Interval 3.448 to 12.89
|
15.599 Units on a scale
Interval 10.355 to 20.843
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit.
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Pain domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=36 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=75 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=64 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Pain Domain Scores of LupusQoL at Week 52
|
15.065 Units on a scale
Interval 10.47 to 19.659
|
15.480 Units on a scale
Interval 9.132 to 21.828
|
16.855 Units on a scale
Interval 12.488 to 21.223
|
24.418 Units on a scale
Interval 19.79 to 29.047
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit.
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Planning domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=36 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=75 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=64 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Planning Domain Scores of LupusQoL at Week 52
|
14.168 Units on a scale
Interval 9.423 to 18.912
|
12.013 Units on a scale
Interval 5.487 to 18.538
|
10.335 Units on a scale
Interval 5.826 to 14.843
|
20.310 Units on a scale
Interval 15.523 to 25.097
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit.
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Fatigue domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=36 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=75 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=64 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52
|
10.317 Units on a scale
Interval 5.951 to 14.683
|
11.893 Units on a scale
Interval 5.892 to 17.894
|
11.701 Units on a scale
Interval 7.55 to 15.853
|
16.443 Units on a scale
Interval 12.036 to 20.85
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit.
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Intimate relationship domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Outcome measures
| Measure |
Placebo
n=56 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=25 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=59 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=42 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52
|
12.430 Units on a scale
Interval 6.842 to 18.019
|
12.625 Units on a scale
Interval 4.112 to 21.139
|
6.494 Units on a scale
Interval 0.96 to 12.027
|
15.363 Units on a scale
Interval 9.078 to 21.647
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure with observed data at the specified visit.
The LupusQoL questionnaire is a validated questionnaire used to evaluate SLE -specific concepts of SLE as reported by participants. It consists of 34 items in 8 different domains: physical health, emotional health, body image, pain, planning, fatigue, intimate relationship, and burden to others measured on a 5-point scale ranging from 0 (not at all) to 4 (very much). The individual domain scores are transformed to a 0 to 100 scale wherein higher scores indicate better quality of life. Burden to others domain score of LupusQoL had score range from 0 to 100, where higher scores = better quality of life.
Outcome measures
| Measure |
Placebo
n=66 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=36 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=75 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=64 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52
|
12.535 Units on a scale
Interval 7.227 to 17.842
|
17.739 Units on a scale
Interval 10.412 to 25.065
|
11.560 Units on a scale
Interval 6.5 to 16.621
|
18.878 Units on a scale
Interval 13.523 to 24.233
|
SECONDARY outcome
Timeframe: Week 52Population: FAS included all participants randomly assigned to study intervention and have received at least 1 dose of study intervention.
Incidence rate was defined as the number of new events per 100 person-years.
Outcome measures
| Measure |
Placebo
n=96 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=47 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=100 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=97 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Incidence Rate of Severe Flare Event
|
8.32 Events per 100 person-years
Interval 3.35 to 17.15
|
6.92 Events per 100 person-years
Interval 1.43 to 20.23
|
3.24 Events per 100 person-years
Interval 0.67 to 9.46
|
6.95 Events per 100 person-years
Interval 2.55 to 15.13
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are events from first dose of study intervention to 4 weeks after last dose of study intervention that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AE)
|
80 Participants
|
38 Participants
|
88 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
8 Participants
|
4 Participants
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. In this outcome measure, participants with adverse events leading to discontinuation from study were reported.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation From Study
|
6 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Vital signs included blood pressure, pulse rate, respiratory rate, and temperature. Clinical significance in vital signs abnormalities was judged by investigator.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Clinical significance in ECG abnormalities was judged by investigator.
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks)Population: Safety analysis set included all participants who were randomly assigned to study intervention and who took at least 1 dose of study intervention.
Hematology (Hemoglobin\[hgb\], hematocrit, erythrocytes\[ery\]:\<0.8\*lower limit of normal\[LLN\];reticulocytes, reticulocytes/ery:\<0.5\*LLN,\>1.5\*upper LN\[ULN\];ery mean corpuscular volume\[EMC\], EMC hgb:\<0.9\*LLN,\>1.5\*ULN;EMC hgb concentration:\<0.9\* LLN;platelet:\<0.5\*LLN;leukocytes\[leu\]:\<0.6\*LLN,\>1.5\*ULN;lymphocytes, lymphocytes/leu, neutrophils, neutrophils/leu:\<0.8\* LLN,\>1.2\*ULN;basophils, basophils/leu, eosinophils, eosinophils/leu, monocytes, monocytes/leu:\>1.2\*ULN;activated partial thromboplastin time\[PTT\], PTT, prothrombin time:\>1.1\*ULN);Clinical chemistry (Total/direct/indirect bilirubin, glucose-fasting:\>1.5\*ULN; aspartate aminotransferase\[AT\], alanine AT:\>3.0\*ULN; protein, albumin, HDL cholesterol:\<0.8\*LLN;urea nitrogen, creatinine, triglyceride, cholesterol:\>1.3\*ULN;urate, LDL cholesterol:\>1.2\*ULN;potassium:\<0.9\*LLN,\>1.1\*ULN;calcium, bicarbonate:\<0.9\*LLN;creatine kinase:\>2.0\*ULN);Urinalysis (pH\<4.5;glucose, protein, hgb, ketones, nitrite, leu esterase, granular/hyaline/WBCs casts:\>1).
Outcome measures
| Measure |
Placebo
n=100 Participants
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 Participants
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 Participants
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 Participants
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
96 Participants
|
48 Participants
|
99 Participants
|
97 Participants
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 47 other events
Deaths: 0 deaths
PF-06700841 15 mg
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
PF-06700841 30 mg
Serious events: 8 serious events
Other events: 53 other events
Deaths: 1 deaths
PF-06700841 45 mg
Serious events: 9 serious events
Other events: 47 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=100 participants at risk
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 participants at risk
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 participants at risk
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 participants at risk
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
1.0%
1/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Intestinal strangulation
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.0%
1/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.0%
1/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.0%
1/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.0%
1/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.0%
1/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
1/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Periorbital cellulitis
|
1.0%
1/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.0%
1/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Investigations
Transaminases increased
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.0%
1/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.0%
2/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
2/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-cell lymphoma
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.0%
1/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
1/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Lupus encephalitis
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.0%
1/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Thalamic stroke
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
1/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Renal and urinary disorders
Lupus nephritis
|
1.0%
1/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Renal and urinary disorders
Renal colic
|
1.0%
1/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
1.0%
1/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Respiratory, thoracic and mediastinal disorders
Lupus pleurisy
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
1/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
Other adverse events
| Measure |
Placebo
n=100 participants at risk
Participants were randomized to receive placebo matched to PF-06700841 QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 15 mg
n=50 participants at risk
Participants were randomized to receive PF-06700841 15 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 30 mg
n=101 participants at risk
Participants were randomized to receive PF-06700841 30 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
PF-06700841 45 mg
n=99 participants at risk
Participants were randomized to receive PF-06700841 45 mg tablets orally QD for 52 weeks. Participants were followed up for 4 weeks after last dose.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
5/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
1/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
6.9%
7/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
6.1%
6/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
5/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
8.0%
4/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
3.0%
3/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
7.1%
7/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
6.0%
3/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
4.0%
4/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
4.0%
4/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
General disorders
Fatigue
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
6/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
2/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
COVID-19
|
17.0%
17/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
18.0%
9/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
10.9%
11/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
10.1%
10/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Cystitis
|
3.0%
3/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
6.0%
3/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
2/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
2/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
7/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
10.0%
5/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
5.9%
6/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
8.1%
8/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.00%
0/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
6.1%
6/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.0%
7/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
1/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
10.9%
11/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
8.1%
8/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Infections and infestations
Urinary tract infection
|
11.0%
11/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
2.0%
1/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
9.9%
10/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
11.1%
11/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Investigations
Blood creatine phosphokinase increased
|
1.0%
1/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
6.0%
3/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
0.99%
1/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
4.0%
4/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
|
Nervous system disorders
Headache
|
5.0%
5/100 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
8.0%
4/50 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
16.8%
17/101 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
9.1%
9/99 • Day 1 of dosing up to 4 weeks after last dose of study drug (maximum up to 56 weeks)
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER