Phase 3
Completed N=418
A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00754572 ↗Enrolled (actual)
418
Serious AEs
7.2%
Results posted
May 2015
Primary outcomePrimary: Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 — 73.23 percentage of participants
Summary
This single arm, open-label study will assess the safety and efficacy with regar d to reduction of signs and symptoms of treatment with tocilizumab in combinatio n with methotrexate, in patients with moderate to severe active rheumatoid arthr itis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexat e 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and th e target sample size is <500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 24 |
73.23 | — |
| SECONDARY Percentage of Participants With ACR20 and ACR70 Response at Week 24 |
90.55; 50.39 | — |
| SECONDARY Time to Onset of ACR20, ACR50, and ACR70 |
— | — |
| SECONDARY Change From Baseline in Hemoglobin at Week 24 |
— | — |
| SECONDARY SJC and TJC at Baseline and Week 24 |
25.06; 4.57; 16.09; 2.56 | — |
| SECONDARY Percent Change From Baseline in SJC and TJC at Week 24 |
81.2; 84.8 | — |
| SECONDARY Pain as Assessed by the Participant at Baseline and Week 24 |
68.01; 22.94 | — |
| SECONDARY Percent Change From Baseline in Pain as Assessed by the Participant at Week 24 |
54.2 | — |
| SECONDARY Participant's Global Assessment of Disease Activity at Baseline and Week 24 |
69.46; 23.60 | — |
| SECONDARY Percent Change From Baseline in Participant's Global Assessment of Disease Activity at Week 24 |
61.7 | — |
| SECONDARY Physician's Global Assessment of Disease Activity at Baseline and Week 24 |
67.32; 17.92 | — |
| SECONDARY Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24 |
71.2 | — |
| SECONDARY HAQ-DI at Baseline and Week 24 |
1.70; 0.79 | — |
| SECONDARY Percent Change From Baseline in HAQ-DI at Week 24 |
52.0 | — |
| SECONDARY Area Under The Curve (AUC) of the ACR(n) |
20.8 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response |
40.10 | — |
| SECONDARY Odds Estimates for ACR Positive Response in Generalized Estimating Equation (GEE) Models |
0.10; 0.33; 0.87; 1.39; 1.55; 1.86 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Week 24 |
4.4 | — |
| SECONDARY Percentage of Participants With a Response by Categorical DAS28 Responses According to The European League Against Rheumatism (EULAR Response) at Week 24 |
68.17; 29.57; 2.26 | — |
| SECONDARY AUC of DAS28 |
11.8 | — |
| SECONDARY Fatigue as Assessed Using the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Score at Week 24 |
39.9 | — |
| SECONDARY Percentage of Participants Achieving Remission (DAS28 Less Than [<] 2.6) at Week 24 |
48.41 | — |
| SECONDARY Quality of Life (QoL) Assessed by Short-Form 36 (SF-36) at Week 24 |
42.5; 63.0; 64.0; 66.0; 48.9; 54.5 | — |
| SECONDARY Mean Change in Rheumatoid Factor (RF) at Week 24 in Participants With Positive RF |
— | — |
Eligibility Criteria
Inclusion Criteria
- patients >=18 years with moderate to severe active RA for at least 6 months;
- swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;
- inadequate response to stable dose of MTX;
- patients of reproductive potential must be using a reliable means of contraception.
Exclusion Criteria
- rheumatic autoimmune disease other than RA;
- patients with functional class IV RA;
- diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
- prior treatment failure with anti-tumor necrosis factor agent;
- pregnant or breastfeeding women.
Data sourced from ClinicalTrials.gov (NCT00754572). 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.