Phase 3
Completed N=317
A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01034137 ↗Enrolled (actual)
317
Serious AEs
15.1%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants Achieving Sustained Remission Rate At Week 104 — 85.8; 83.5; 44.4 Percentage of participants — p=< 0.001
◆ Published Evidence
Established
51citations · ~6 / year
Inadequate response to treat-to-target methotrexate therapy in patients with new-onset rheumatoid arthritis: development and validation of clinical predictors.
Summary
This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.
Linked Publications (5)
-
Inadequate response to treat-to-target methotrexate therapy in patients with new-onset rheumatoid arthritis: development and validation of clinical predictors.
-
Baseline metabolic profiles of early rheumatoid arthritis patients achieving sustained drug-free remission after initiating treat-to-target tocilizumab, methotrexate, or the combination: insights from systems biology.
-
Radiographic joint damage in early rheumatoid arthritis patients: comparing tocilizumab- and methotrexate-based treat-to-target strategies.
-
Validation of a Prognostic Multivariable Prediction Model for Insufficient Clinical Response to Methotrexate in Early Rheumatoid Arthritis and Its Clinical Application in Evidencio.
-
Patient-reported outcomes in newly diagnosed early rheumatoid arthritis patients treated to target with a tocilizumab- or methotrexate-based strategy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Remission Rate At Week 104 |
85.8; 83.5; 44.4 | < 0.001 sig |
| SECONDARY Median Time to First Sustained Remission |
69.00; 89.00; NA | — |
| SECONDARY Mean Duration of First Sustained Remission |
65.85; 65.00; 52.90 | — |
| SECONDARY Number of Participants Achieving Disease Activity Score 28 Remission at Weeks 12, 24, 52, and 104 |
76; 66; 23; 84; 77; 42 | — |
| SECONDARY Median Time to First Disease Activity Score 28 Remission |
56.00; 57.00; 167.00 | — |
| SECONDARY Percentage of Participants With Cumulative Remission Rate at Weeks 12, 24, 52, and 104 |
72.4; 64.7; 21.7; 80.0; 75.5; 39.6 | — |
| SECONDARY Mean Duration of First Disease Activity Score 28 Remission |
42.99; 37.01; 20.49 | — |
| SECONDARY Absolute Change From Baseline in Disease Activity Score 28 at Weeks 12, 24, 52, and 104 |
3.1; 3.3; 1.4; 3.6; 3.6; 2.1 | — |
| SECONDARY Median Change From Baseline in Clinical Disease Activity Index Score at Weeks 24, 52, and 104 |
-20.0; -20.0; -14.8; -19.5; -21.0; -18.0 | — |
| SECONDARY Median Change From Baseline in Simplified Disease Activity Index Scores at Weeks 24, 52, and 104 |
-31.0; -32.8; -21.5; -26.3; -33.5; -27.9 | — |
| SECONDARY Number of Participants With Good European League Against Rheumatism Response Rate at Weeks 24, 52, and 104 |
93; 84; 50; 75; 85; 71 | — |
| SECONDARY Median Time to First European League Against Rheumatism Response |
35.5; 47.0; 132.0; 29.0; 29.0; 57.0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 20 Response Rate at Weeks 12, 24, 52 and 104 |
63.8; 67.6; 41.5; 75.2; 75.5; 59.4 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 50 Response Rate at Weeks 12, 24, 52 and 104 |
47.6; 44.1; 21.7; 63.8; 58.8; 34.0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 70 Response Rate at Weeks 12, 24, 52 and 104 |
30.5; 23.5; 7.5; 43.8; 37.3; 15.1 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 90 Response Rate at Weeks 12, 24, 52 and 104 |
9.5; 3.9; 0.0; 18.1; 11.8; 4.7 | — |
| SECONDARY Mean Percent Change From Baseline in the Swollen Joint Count (SJC) at Weeks 12, 24, 52, and 104 |
-69.2; -68.2; -44.9; -91.7; -86.9; -69.3 | — |
| SECONDARY Mean Percent Change From Baseline in the Tender Joint Count (TJC) at Weeks 12, 24, 52, and 104 |
-68.0; -53.7; -36.9; -81.9; -66.1; -66.6 | — |
| SECONDARY Mean Percent Change From Baseline in Patient Health Visual Analog Scale at Weeks 12, 24, 52, and 104 |
-43.8; -40.8; -25.3; -66.5; -54.8; -41.5 | — |
| SECONDARY Mean Percent Change From Baseline in The Physician Health Visual Analog Scale at Weeks 12, 24, 52, and 104 |
-41.6; -36.5; -18.2; -61.0; -46.7; -26.1 | — |
| SECONDARY Mean Percent Change From Baseline in Pain Visual Analog Scale at Weeks 12, 24, 52, and 104 |
-59.3; -55.8; -39.1; -74.9; -70.3; -48.6 | — |
| SECONDARY Mean Percent Change From Baseline in CRP at Weeks 12, 24, 52, and 104 |
-47.4; -69.8; -28.5; -64.4; -69.1; -16.8 | — |
| SECONDARY Mean Change From Baseline in Modified Sharp/Van Der Heijde Score at Weeks 52 and 104 |
0.50; 0.79; 0.96; 1.18; 1.45; 1.53 | — |
| SECONDARY Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response |
32.1; 18.2; 43.3 | — |
| SECONDARY Number of Participants With Change in The Therapy Strategy During The Study |
0; 13; 50; 9; 2; 2 | — |
| SECONDARY Mean Change From Baseline in The Dutch Consensus Health Assessment Questionnaire of Quality of Life at Weeks 12, 24, 52, and 104 |
-0.5; -0.5; -0.2; -0.7; -0.6; -0.4 | — |
| SECONDARY Mean Change From Baseline in The EuroQol Score of Quality of Life at Weeks 12, 24, 52 and 104 |
0.15; 0.19; 0.11; 11.94; 9.31; 2.92 | — |
| SECONDARY Mean Change From Baseline in 36-Item Short Form Health Survey of Quality of Life at Weeks 12, 24, 52, and 104 |
11.2; 14.2; 6.8; 6.2; 10.9; 3.9 | — |
| SECONDARY Mean Change From Baseline in Patient Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104 |
-25.8; -24.2; -14.8; -33.9; -29.2; -20.4 | — |
| SECONDARY Mean Change From Baseline in Physician Global Health Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104 |
-35.4; -34.6; -23.0; -43.9; -43.8; -31.0 | — |
| SECONDARY Mean Change From Baseline in Patient Pain Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104 |
-28.7; -29.5; -19.7; -36.4; -33.5; -28.0 | — |
| SECONDARY Mean Change From Baseline in Patient General Wellbeing Visual Analog Scale Score of Quality of Life at Weeks 12, 24, 52, and 104 |
-27.3; -31.1; -6.6; -36.1; -35.6; -16.1 | — |
| SECONDARY Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Score of Quality of Life at Weeks 12, 24, 52, and 104 |
4.3; 6.5; 3.4; 7.3; 6.7; 4.4 | — |
| SECONDARY Mean Change From Baseline in The Revised Illness Perception Questionnaire (IPQ-R) Score of Quality of Life at Week 12 |
-0.6; -0.8; -0.1; -0.1; -0.0; 0.0 | — |
| SECONDARY Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 24 |
-1.2; -1.0; -0.3; -0.0; 0.1; 0.0 | — |
| SECONDARY Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 52 |
-1.0; -1.4; -1.0; -0.1; 0.1; 0.1 | — |
| SECONDARY Mean Change From Baseline in The IPQ-R Score of Quality of Life at Week 104 |
-1.0; -1.3; -0.9; 0.0; 0.3; 0.3 | — |
| SECONDARY Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Adverse Events Leading to Discontinuation |
105; 99; 106; 16; 19; 13 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Values at Week 12 |
2; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Values at Week 24 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Values at Week 52 |
0; 0; 0; 0; 0; 4 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Values at Week 104 |
0; 0; 1; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >/=18 years of age
- early rheumatoid arthritis (disease symptoms 2.6
- body weight </=110kg, BMI </=36
Exclusion Criteria
- rheumatic autoimmune disease other than RA
- current inflammatory joint disease other than RA
- previous treatment with any DMARD or biologic drug used in the treatment of RA
- intra-articular, parenteral or oral glucocorticoids used for the arthritis
Data sourced from ClinicalTrials.gov (NCT01034137) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.