A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
CompletedPhase 3Results postedLast updated 26 July 2017
What this trial tests
Phase 3 trial testing Tocilizumab in Rheumatoid Arthritis in 1,162 participants. Completed in 28 January 2014.
18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24Primary· Week 24
A participant has a DAS28 remission response if their DAS28 \< 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog sca
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
15.0
10.9 – 19.1
Tocilizumab 4 mg/kg + Methotrexate
31.9
26.6 – 37.3
Tocilizumab 8 mg/kg + Methotrexate
44.8
39.1 – 50.6
Tocilizumab 8 mg/kg + Placebo to Methotrexate
38.7
33.1 – 44.3
Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52Secondary· Week 52
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
19.5
Tocilizumab 4 mg/kg + Methotrexate
34.0
Tocilizumab 8 mg/kg + Methotrexate
49.0
Tocilizumab 8 mg/kg + Placebo to Methotrexate
39.4
Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52Secondary· Baseline to Weeks 24 and 52
Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" \[symptom-free and no arthritis symptoms\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a V
Week 24: ACR 20
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
65.2
Tocilizumab 4 mg/kg + Methotrexate
73.6
Tocilizumab 8 mg/kg + Methotrexate
74.5
Tocilizumab 8 mg/kg + Placebo to Methotrexate
70.2
Week 24: ACR 50
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
43.2
Tocilizumab 4 mg/kg + Methotrexate
47.9
Tocilizumab 8 mg/kg + Methotrexate
56.9
Tocilizumab 8 mg/kg + Placebo to Methotrexate
47.6
Week 24: ACR 70
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
25.4
Tocilizumab 4 mg/kg + Methotrexate
34.7
Tocilizumab 8 mg/kg + Methotrexate
38.6
Tocilizumab 8 mg/kg + Placebo to Methotrexate
30.1
Week 52: ACR 20
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
57.1
Tocilizumab 4 mg/kg + Methotrexate
62.8
Tocilizumab 8 mg/kg + Methotrexate
67.2
Tocilizumab 8 mg/kg + Placebo to Methotrexate
63.0
Week 52: ACR 50
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
40.8
Tocilizumab 4 mg/kg + Methotrexate
52.4
Tocilizumab 8 mg/kg + Methotrexate
55.9
Tocilizumab 8 mg/kg + Placebo to Methotrexate
49.3
Week 52: ACR 70
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
28.9
Tocilizumab 4 mg/kg + Methotrexate
37.2
Tocilizumab 8 mg/kg + Methotrexate
43.1
Tocilizumab 8 mg/kg + Placebo to Methotrexate
36.0
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52Secondary· Baseline to Week 52
The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand j
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
1.14
± 4.297
Tocilizumab 4 mg/kg + Methotrexate
0.42
± 2.929
Tocilizumab 8 mg/kg + Methotrexate
0.08
± 2.090
Tocilizumab 8 mg/kg + Placebo to Methotrexate
0.26
± 1.876
Change From Baseline in Modified Sharp Erosion Score at Week 52Secondary· Baseline to Week 52
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
0.63
± 2.556
Tocilizumab 4 mg/kg + Methotrexate
0.25
± 1.686
Tocilizumab 8 mg/kg + Methotrexate
0.05
± 1.736
Tocilizumab 8 mg/kg + Placebo to Methotrexate
0.15
± 1.544
Change From Baseline in Sharp Joint Space Narrowing Score at Week 52Secondary· Baseline to Week 52
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
0.51
± 2.362
Tocilizumab 4 mg/kg + Methotrexate
0.17
± 1.645
Tocilizumab 8 mg/kg + Methotrexate
0.03
± 0.751
Tocilizumab 8 mg/kg + Placebo to Methotrexate
0.11
± 1.046
Percentage of Participants With a Major Clinical Response at Week 52Secondary· Baseline to Week 52
A major clinical response is defined as an ACR70 response that is maintained for 6 consecutive months (24 weeks) for any 24-week period between Week 2 and Week 52.
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
16
Tocilizumab 4 mg/kg + Methotrexate
22
Tocilizumab 8 mg/kg + Methotrexate
31
Tocilizumab 8 mg/kg + Placebo to Methotrexate
22
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52Secondary· Baseline to Weeks 24 and 52
The Stanford HAQ-DI is a patient completed questionnaire specific for rheumatoid arthritis. The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative cha
Week 24 (n=246, 255, 250, 265)
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
-0.71
± 0.718
Tocilizumab 4 mg/kg + Methotrexate
-0.92
± 0.736
Tocilizumab 8 mg/kg + Methotrexate
-0.91
± 0.695
Tocilizumab 8 mg/kg + Placebo to Methotrexate
-0.82
± 0.739
Week 52 (n=214, 227, 228, 230)
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
-0.76
± 0.800
Tocilizumab 4 mg/kg + Methotrexate
-1.00
± 0.795
Tocilizumab 8 mg/kg + Methotrexate
-0.97
± 0.700
Tocilizumab 8 mg/kg + Placebo to Methotrexate
-0.87
± 0.776
Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52Secondary· Baseline to Weeks 24 and 52
The SF-36 Health Survey (Version 2) is a standardized questionnaire consisting of 36 questions that measures patient-reported symptoms on 8 dimensions; it is used to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100. A positive change score indicates better HRQoL.
Week 24 (n=237, 247, 246, 255)
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
9.35
± 9.763
Tocilizumab 4 mg/kg + Methotrexate
11.33
± 9.282
Tocilizumab 8 mg/kg + Methotrexate
12.13
± 9.263
Tocilizumab 8 mg/kg + Placebo to Methotrexate
10.75
± 10.055
Week 52 (n=204, 225, 221, 224)
Group
Value
95% CI
Placebo to Tocilizumab + Methotrexate
10.72
± 10.389
Tocilizumab 4 mg/kg + Methotrexate
12.27
± 10.509
Tocilizumab 8 mg/kg + Methotrexate
13.52
± 9.848
Tocilizumab 8 mg/kg + Placebo to Methotrexate
11.73
± 10.691
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from Baseline through Week 52..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 26 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01007435.