Trial Outcomes & Findings for A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy (NCT NCT03001219)
NCT ID: NCT03001219
Last Updated: 2020-01-29
Results Overview
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
109 participants
Primary outcome timeframe
Baseline to last participant last visit (approximately 2 years)
Results posted on
2020-01-29
Participant Flow
Adult men and women with moderate to severe active rheumatoid arthritis (RA) who experience an inadequate response to disease-modifying anti-rheumatic drug (DMARD) therapy with MTX plus anti-TNF-a therapy.
Arms are not mutually exclusive. Proof of Concept: 109 total participants enrolled. Extension Period Analysis: 106 participants from the previous groups, including placebo, received 360 (n=9) or 810 mg/dose (n=97) of RO7123520. Part 3 was not conducted due to early study termination.
Participant milestones
| Measure |
PoC Placebo to Extension Period Analysis RO7123520
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56. Participants from this group that continued to the Extension Period Analysis period were assigned RO7123520 + pre-trial anti-TNF-alpha and MTX at either 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
RO70123520 360 or 810 mg/Dose
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56. Participants continuing to the Extension Period Analysis period received 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|
|
Proof of Concept
STARTED
|
37
|
72
|
|
Proof of Concept
COMPLETED
|
35
|
65
|
|
Proof of Concept
NOT COMPLETED
|
2
|
7
|
|
Extension Period Analysis
STARTED
|
9
|
97
|
|
Extension Period Analysis
COMPLETED
|
4
|
52
|
|
Extension Period Analysis
NOT COMPLETED
|
5
|
45
|
Reasons for withdrawal
| Measure |
PoC Placebo to Extension Period Analysis RO7123520
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56. Participants from this group that continued to the Extension Period Analysis period were assigned RO7123520 + pre-trial anti-TNF-alpha and MTX at either 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
RO70123520 360 or 810 mg/Dose
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56. Participants continuing to the Extension Period Analysis period received 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|
|
Proof of Concept
Study Termination by Sponsor
|
0
|
1
|
|
Proof of Concept
Withdrawal by Subject
|
0
|
4
|
|
Proof of Concept
Protocol Deviation
|
0
|
1
|
|
Proof of Concept
Adverse Event
|
1
|
1
|
|
Proof of Concept
Physician Decision
|
1
|
0
|
|
Extension Period Analysis
Study Termination by Sponsor
|
0
|
36
|
|
Extension Period Analysis
Participant Non-Compliance
|
0
|
1
|
|
Extension Period Analysis
Physician Decision
|
0
|
1
|
|
Extension Period Analysis
Adverse Event
|
1
|
1
|
|
Extension Period Analysis
Protocol Deviation
|
0
|
1
|
|
Extension Period Analysis
Withdrawal by Subject
|
4
|
5
|
Baseline Characteristics
The proof of concept groups included 37 participants receiving placebo treatment and 72 participants receiving 810 mg/dose of RO7123520.
Baseline characteristics by cohort
| Measure |
PoC Placebo to Extension Period Analysis RO7123520
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56. Participants from this group that continued to the Extension Period Analysis period were assigned RO7123520 + pre-trial anti-TNF-alpha and MTX at either 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
RO70123520 360 or 810 mg/Dose
n=97 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56. Participants continuing to the Extension Period Analysis period received 360 or 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 Years
STANDARD_DEVIATION 14.3 • n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
53.4 Years
STANDARD_DEVIATION 12.8 • n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
53.7 Years
STANDARD_DEVIATION 12.9 • n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
87 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
93 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Sex: Female, Male
Male
|
3 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
10 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
13 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
73 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
74 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
24 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
32 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
0 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
0 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
16 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
16 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
0 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
0 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
0 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
0 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
2 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
4 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Race (NIH/OMB)
White
|
7 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
68 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
75 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
6 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
6 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
5 Participants
n=97 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
5 Participants
n=106 Participants • The extension period analysis population contained participants from period 1 of the study. Participants were assigned either 360 (n=9) or 810 (n=97) mg/dose and grouped accordingly.
|
PRIMARY outcome
Timeframe: Baseline to last participant last visit (approximately 2 years)Population: The safety population included all participants who received at least one dose of study medication.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=70 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
|
48.6 Percentage of Participants
|
60.0 Percentage of Participants
|
66.7 Percentage of Participants
|
60.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants. Overall study = up to 32 weeks per participant. PoC = Weeks 1-12, Extension Period Analysis = Weeks 1-20 (overall study weeks 13-32)
The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=72 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Proportion of Participants Achieving an American College of Rheumatology (ACR) 50 Response at Week 12
|
16.2 Percent
Interval 7.67 to 29.95
|
11.1 Percent
Interval 5.86 to 19.48
|
0 Percent
Interval 0.0 to 30.89
|
1.0 Percent
Interval 0.07 to 5.28
|
PRIMARY outcome
Timeframe: BaselinePopulation: This outcome measure only includes the immunogenicity population, which was the PoC 810 mg dose group. These participants had at least 1 pre-dose ADA assessment.
Outcome measures
| Measure |
Placebo
n=69 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Percentage of Participants With Anti-Drug Antibodies
|
0 Percent
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The safety population included all participants who received at least one dose of study medication.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=70 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Change From Baseline in Bone Mineral Density Lumbar Spine L1-L4 as Assessed by Dual Energy X-ray Absorptiometry (DEXA) Scans
Baseline
|
1.02 g/cm^2
Standard Deviation 0.21
|
2.51 g/cm^2
Standard Deviation 12.46
|
1.17 g/cm^2
Standard Deviation 0.20
|
2.06 g/cm^2
Standard Deviation 10.53
|
|
Change From Baseline in Bone Mineral Density Lumbar Spine L1-L4 as Assessed by Dual Energy X-ray Absorptiometry (DEXA) Scans
Week 12
|
-0.06 g/cm^2
Standard Deviation 0.20
|
0.71 g/cm^2
Standard Deviation 5.50
|
-0.01 g/cm^2
Standard Deviation 0.04
|
0.58 g/cm^2
Standard Deviation 4.98
|
SECONDARY outcome
Timeframe: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants.
The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=72 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
Baseline
|
37.05 Units on a scale
Standard Deviation 10.99
|
37.38 Units on a scale
Standard Deviation 13.14
|
30.89 Units on a scale
Standard Deviation 15.31
|
32.17 Units on a scale
Standard Deviation 15.91
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
Week 12
|
-17.44 Units on a scale
Standard Deviation 15.11
|
-14.44 Units on a scale
Standard Deviation 13.96
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants.
The DAS28 is a combined index for measuring disease activity in RA; the "28" refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=72 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 12
Baseline
|
6.29 Units on a scale
Standard Deviation 0.78
|
6.28 Units on a scale
Standard Deviation 1.03
|
5.42 Units on a scale
Standard Deviation 1.63
|
5.82 Units on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 12
Week 12
|
-1.62 Units on a scale
Standard Deviation 1.28
|
-1.15 Units on a scale
Standard Deviation 1.06
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants.
The DAS28 is a combined index for measuring disease activity in RA; the "28" refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=66 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving DAS28 Remission at Week 12
|
0 Percent
|
1.4 Percent
|
0 Percent
|
0 Percent
|
SECONDARY outcome
Timeframe: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants.
The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity. CDAI remission is defined as a score of less than or equal to 2.8.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=66 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving CDAI Remission at Week 12
|
0 Percent
|
1.4 Percent
|
0 Percent
|
0 Percent
|
SECONDARY outcome
Timeframe: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants.
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=72 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving ACR20 Response at Week 12
|
43.2 Percent
Interval 29.55 to 57.94
|
27.8 Percent
Interval 19.42 to 37.88
|
0 Percent
Interval 0.0 to 30.89
|
11.3 Percent
Interval 6.66 to 18.32
|
SECONDARY outcome
Timeframe: Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants.
The ACR70 is a composite measure defined as both improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=72 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Percentage of Participants Achieving ACR70 Response at Week 12
|
0 Percent
Interval 0.0 to 9.15
|
1.4 Percent
Interval 0.1 to 7.04
|
0 Percent
Interval 0.0 to 30.89
|
0 Percent
Interval 0.0 to 3.65
|
SECONDARY outcome
Timeframe: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants.
The SDAI consists of 5 parameters used to assess RA disease activity: 28-joint count assessments of tenderness and swelling, participant and investigator global assessments, and CRP levels. A composite score is produced, with remission defined as an SDAI of \<3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as \>26.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=72 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 12
Baseline
|
38.84 Scores on a scale
Standard Deviation 10.58
|
39.02 Scores on a scale
Standard Deviation 14.55
|
31.23 Scores on a scale
Standard Deviation 15.25
|
34.08 Scores on a scale
Standard Deviation 16.69
|
|
Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 12
Week 12
|
-17.48 Scores on a scale
Standard Deviation 14.48
|
-14.99 Scores on a scale
Standard Deviation 15.19
|
-15.33 Scores on a scale
Standard Deviation 18.24
|
-13.15 Scores on a scale
Standard Deviation 14.56
|
SECONDARY outcome
Timeframe: Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)Population: The efficacy population included all randomized participants.
The HAQ-DI is a 20-item, validated questionnaire used to assess difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming (2 items), Hygiene (3 items), Arising (2 items), Reach (2 items), Eating (3 items), Grip (3 items), Walking (2 items), Common Daily Activities (3 items). The questions assess usual abilities ranging from 0 "without any difficulty" to 3 "unable to do." A lower HAQ-DI score indicates better quality of life. Subscale scores are combined and the mean value is reported for each arm per timepoint.
Outcome measures
| Measure |
Placebo
n=37 Participants
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=72 Participants
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 Participants
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 Participants
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Change From Baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Baseline
|
1.63 Units on a scale
Standard Deviation 0.64
|
1.61 Units on a scale
Standard Deviation 0.76
|
1.29 Units on a scale
Standard Deviation 0.70
|
1.59 Units on a scale
Standard Deviation 0.71
|
|
Change From Baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Week 12
|
-0.15 Units on a scale
Standard Deviation 0.52
|
-0.24 Units on a scale
Standard Deviation 0.51
|
-0.21 Units on a scale
Standard Deviation 0.74
|
-0.21 Units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1 hour post infusion (duration of infusion: approximately 1 hour) on Days 1, 14, 28, 56; Pre-dose (0 hour) on Days 84, 112Population: All enrolled participants were included in the PK population. No PK analysis was performed due to an insufficient number of available participant samples for processing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose (0 hour) on Days 1, 84Population: All enrolled participants were included in the PK population. No PK analysis was performed due to an insufficient number of available participant samples for processing.
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Proof of Concept: RO7123520 810mg/Dose
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Extension Period Analysis: RO7123520 360mg/Dose
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Extension Period Analysis: RO70123520 810mg/Dose
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=37 participants at risk
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=70 participants at risk
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 participants at risk
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 participants at risk
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Infections and infestations
Arthritis bacterial
|
2.7%
1/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
1.4%
1/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=37 participants at risk
In the Proof of Concept (PoC) period, participants received placebo (IV saline matched to RO7123520) + pre-trial anti-TNF-alpha and methotrexate (MTX), on Days 1, 14, 28, and 56.
|
Proof of Concept: RO7123520 810mg/Dose
n=70 participants at risk
In the PoC period, participants not assigned placebo received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose on Days 1, 14, 28, and 56.
|
Extension Period Analysis: RO7123520 360mg/Dose
n=9 participants at risk
Participants received 360 mg/dose of RO7123520 + pre-trial anti-TNF-alpha and MTX up to Week 20 of the Extension Period (overall study Week 32).
|
Extension Period Analysis: RO70123520 810mg/Dose
n=97 participants at risk
Participants received RO7123520 + pre-trial anti-TNF-alpha and MTX at 810 mg/dose up to Week 20 of the Extension Period (overall study Week 32).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
3.1%
3/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
1.0%
1/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
2.1%
2/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
9.3%
9/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.7%
1/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
5.7%
4/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
5.7%
4/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
8.1%
3/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
1.4%
1/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
1.0%
1/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.4%
2/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
1.4%
1/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
1.0%
1/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.4%
2/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
5.4%
2/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
1.0%
1/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/37 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/70 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
11.1%
1/9 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
0.00%
0/97 • Baseline to last participant last visit (approximately 2 years)
The safety population included participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER