Trial Outcomes & Findings for A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis. (NCT NCT00773461)

Last Updated: 2017-08-01

Results Overview

To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward \[LOCF\]).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

209 participants

Primary outcome timeframe

Week 24

Results posted on

2017-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo + DMARDs Participants received placebo intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy	Tocilizumab + DMARDs Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
Overall Study STARTED	70	139
Overall Study COMPLETED	65	135
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo + DMARDs Participants received placebo intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy	Tocilizumab + DMARDs Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy
Overall Study Adverse Event	1	3
Overall Study Withdrawal by Subject	4	1

Baseline Characteristics

A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo + DMARDs n=69 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Total n=208 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 11.68 • n=5 Participants	46.8 years STANDARD_DEVIATION 11.01 • n=7 Participants	47.1 years STANDARD_DEVIATION 11.22 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	120 Participants n=7 Participants	175 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=69 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24 ITT Population	24.6 Percentage of Participants	69.8 Percentage of Participants
Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24 ITT Population (Sensitivity)	24.6 Percentage of Participants	73.4 Percentage of Participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population

To achieve an ACR50 or ACR 70 response required at least a 50% or 70% improvement, compared with baseline in both TJC and SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, HAQ-DI and CRP. CRP was used primarily for the calculation of the ACR response; if missing, ESR was substituted.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=69 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Percentage of Participants With ACR50 and ACR70 Responses at Week 24 ACR 50	10.1 Percentage of Participants	38.8 Percentage of Participants
Percentage of Participants With ACR50 and ACR70 Responses at Week 24 ACR 70	2.9 Percentage of Participants	12.9 Percentage of Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: ITT Population

Participants who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 could, if requested and deemed necessary by the investigator, receive escape therapy, comprising adjustment of the background DMARD dose and/or treatment with a different traditional DMARD.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=69 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Number of Participants Who Received Escape Therapy	4 Number of participants	0 Number of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population

68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=69 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change in Tender and Swollen Joint Counts From Baseline to Week 24 Swollen Joint Count	-4.5 Joints Standard Deviation 11.61	-9.9 Joints Standard Deviation 9.26
Change in Tender and Swollen Joint Counts From Baseline to Week 24 Tender Joint Count	-6.2 Joints Standard Deviation 12.31	-16.5 Joints Standard Deviation 12.06

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population

The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=65 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=132 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24	-8.7 mm Standard Deviation 26.27	-26.4 mm Standard Deviation 24.69

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population

The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity).

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=65 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=132 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24	-9.9 mm Standard Deviation 22.61	-29.1 mm Standard Deviation 22.43

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population

The participants assessed their pain on a 0 to 100 mm VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=65 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=132 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change in Participant's Global Assessment of Pain From Baseline to Week 24	-5.9 mm Standard Deviation 23.97	-23.5 mm Standard Deviation 25.78

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population

The serum concentration of CRP an acute phase inflammatory marker, is measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=65 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=132 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change in C-Reactive Protein From Baseline to Week 24	-0.083 mg/dL Standard Deviation 2.310	-1.865 mg/dL Standard Deviation 2.152

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population

The ESR was measured in mm/hour. A reduction in the level is considered an improvement.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=64 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=131 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change in ESR From Baseline to Week 24	-4.4 mm/hour Standard Deviation 22.46	-42.7 mm/hour Standard Deviation 26.23

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24

Population: ITT Population; n=number of participants analyzed.

DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, ESR and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=69 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Percentage of Participants With Low Disease Activity and in Clinical Remission Baseline Low Disease Activity (n= 69,139)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Baseline Remission (n=69, 139)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Baseline Remission first achieved (n=69, 139)	0 Percentage of Participants	0 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 2 Low Disease Activity (n= 67,138)	0 Percentage of Participants	2.2 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 2 Remission (n= 67,138)	0 Percentage of Participants	0.7 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 2 Remission first achieved (n= 67,138)	0 Percentage of Participants	0.7 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 4 Low Disease Activity (n= 67,139)	0 Percentage of Participants	12.9 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 4 Remission (n=67,139)	0 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 4 Remission first achieved (n=67,139)	0 Percentage of Participants	5.0 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 8 Low Disease Activity (n= 67,139)	1.5 Percentage of Participants	24.5 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 8 Remission (n=67,139)	0 Percentage of Participants	12.9 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 8 Remission first achieved (n=67,139)	0 Percentage of Participants	8.6 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 12 Low Disease Activity (n=65,138)	3.1 Percentage of Participants	37.7 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 12 Remission (n=65,138)	3.1 Percentage of Participants	21.0 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 12 Remission first achieved (n=65,138)	3.1 Percentage of Participants	10.1 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 16 Low Disease Activity (n=65,136)	6.2 Percentage of Participants	39.0 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 16 Remission (n=65,136)	1.5 Percentage of Participants	24.3 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 16 Remission first achieved (n=65,136)	1.5 Percentage of Participants	7.4 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 20 Low Disease Activity (n=63,134)	3.2 Percentage of Participants	46.3 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 20 Remission (n=63,134)	0 Percentage of Participants	29.1 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 20 Remission first achieved (n=63,134)	0 Percentage of Participants	7.5 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 24 Low Disease Activity (n=64,131)	4.7 Percentage of Participants	46.6 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 24 Remission (n=64,131)	3.1 Percentage of Participants	30.5 Percentage of Participants
Percentage of Participants With Low Disease Activity and in Clinical Remission Week 24 Remission first achieved (n=64,131)	1.6 Percentage of Participants	4.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: ITT Population

FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in health status.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=61 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=132 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score	2.08 units on a scale Standard Deviation 7.684	6.51 units on a scale Standard Deviation 9.244

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: ITT Population

Rheumatoid factor (RF) is a disease characteristic and more than 85% of the participants studied were positive for the factor. These data are from patients who were RF positive. RF level was reported in international units/milliliter (IU/mL). A positive RF= \>15 IU/mL.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=61 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=125 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Mean Rheumatoid Factor at Baseline and Week 24 Baseline, n = 61, 125	179.5 IU/mL Standard Deviation 199.57	262.2 IU/mL Standard Deviation 360.39
Mean Rheumatoid Factor at Baseline and Week 24 Week 24, n = 57, 118	198.6 IU/mL Standard Deviation 277.06	204.6 IU/mL Standard Deviation 365.25

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: ITT Population

Levels of hemoglobin were determined in grams/liter (g/L)as a measure of anemia in participants

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=65 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=131 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change in Hemoglobin From Baseline to Week 24	-1.0 g/L Standard Deviation 11.7	12.0 g/L Standard Deviation 14.1

SECONDARY outcome

Timeframe: Baseline and 24 Weeks

Population: ITT Population

HAQ-DI is a self-completed participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=65 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=132 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24	-0.06 units on a scale Standard Deviation 0.522	-0.52 units on a scale Standard Deviation 0.554

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24

Population: ITT Population

ACR 20 responses are summarized by first onset as a percentage of the total number of responders at week 24. The number of participants first achieving an ACR20 response at each time point is represented by treatment arm as a proportion of the total number of participants that had an ACR20 response at Week 24 using n as the denominator.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=17 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=97 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Percentage of Participants With ACR20 Response by First Week of Onset First onset at Week 2	17.6 Percentage of Participants	21.6 Percentage of Participants
Percentage of Participants With ACR20 Response by First Week of Onset First onset at Week 4	23.5 Percentage of Participants	22.7 Percentage of Participants
Percentage of Participants With ACR20 Response by First Week of Onset First onset at Week 8	5.9 Percentage of Participants	30.9 Percentage of Participants
Percentage of Participants With ACR20 Response by First Week of Onset First onset at Week 12	17.6 Percentage of Participants	15.5 Percentage of Participants
Percentage of Participants With ACR20 Response by First Week of Onset First onset at Week 16	0 Percentage of Participants	5.2 Percentage of Participants
Percentage of Participants With ACR20 Response by First Week of Onset First onset at Week 20	17.6 Percentage of Participants	1.0 Percentage of Participants
Percentage of Participants With ACR20 Response by First Week of Onset First onset at Week 24	17.6 Percentage of Participants	3.1 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24

Population: ITT Population

Time to Low disease activity was calculated as the number of days from the first dose of drug administration to the date of first achievement of DAS28≤3.2.

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=69 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Time to First Low Disease Activity	NA Days Interval 172.0 to value not calculable due to insufficient events.	139 Days Interval 113.0 to 169.0

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, and 24

Population: ITT Population

Time to first Remission was calculated as the number of days from the date of first dose of study drug administration to the date of first achievement of DAS\<2.6

Outcome measures

Outcome measures
Measure	Placebo + DMARDs n=69 Participants Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 Participants Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Time to First Remission	NA Days value not calculable due to insufficient events.	NA Days Interval 169.0 to value not calculable due to insufficient events.

Adverse Events

Placebo + DMARDs

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Tocilizumab + DMARDs

Serious events: 1 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo + DMARDs n=68 participants at risk Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy	Tocilizumab + DMARDs n=139 participants at risk Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
Infections and infestations Abscess Limb	1.5% 1/68 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.	0.00% 0/139 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.
Infections and infestations Herpes Zoster	1.5% 1/68 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.	0.00% 0/139 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.
Infections and infestations Uterine Infection	1.5% 1/68 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.	0.00% 0/139 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.
General disorders Pyrexia	1.5% 1/68 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.	0.00% 0/139 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.
Investigations Neutrophil Count Decreased	0.00% 0/68 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.	0.72% 1/139 • Adverse events were monitored and recorded throughout the study. There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.

Other adverse events

Additional Information

Medical Communications

Hoffmann- LaRoche

Phone: 800-821-8590

Email: [email protected]

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 after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
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Restriction type: OTHER