Phase 4
Completed N=261
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Source: ClinicalTrials.gov NCT01399697 ↗Enrolled (actual)
261
Serious AEs
4.0%
Results posted
Jul 2015
Primary outcomePrimary: Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28 — 5.42; 5.29; 1.77; 1.96 units on a scale — p=0.700
Summary
This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28 |
5.42; 5.29; 1.77; 1.96; 1.82; 1.98 | 0.700 |
| SECONDARY Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28 |
82.3; 75.9 | 0.328 |
| SECONDARY Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28 |
40.7; 35.8 | 0.518 |
| SECONDARY Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28 |
35.1; 28.2 | 0.358 |
| SECONDARY Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28 |
0.08; 0.00 | 0.674 |
| SECONDARY Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health |
-2.36; -0.38 | 0.204 |
| SECONDARY Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health |
0.48; -2.26 | 0.015 sig |
| SECONDARY Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant |
1.68; 0.56 | 0.769 |
| SECONDARY Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator |
2.71; 2.85 | 0.655 |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline
- Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
- Body weight < 150 kg
- Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day
Exclusion Criteria
- Pregnant or nursing women
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
- Rheumatic autoimmune disease other than RA
- Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
- Prior history of or current inflammatory joint disease other than RA
- Treatment with a biologic agent at any time prior to baseline
- Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Previous treatment with RoActemra/Actemra
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Known active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for HIV infection
Data sourced from ClinicalTrials.gov (NCT01399697). 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.