Phase 3
N=77
A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01587989 ↗Enrolled (actual)
77
Serious AEs
10.8%
Results posted
Jul 2015
Primary outcome: Primary: Change From Week 12 (Randomization) to Week 24 in DAS28 — 0.17; -0.16 score on a scale — p=0.188
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- methotrexate (Drug); placebo (Drug); tocilizumab [RoActemra/Actemra] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Week 12 (Randomization) to Week 24 in DAS28 |
0.17; -0.16 | 0.188 |
| SECONDARY Percentage of Participants With DAS28 Remission at Week 24 |
81.25; 87.50 | 0.732 |
| SECONDARY vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 |
34.38; 53.13 | 0.207 |
| SECONDARY Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24 |
40.63; 53.13 | 0.453 |
| SECONDARY Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24 |
32.26; 54.55 | 0.084 |
| SECONDARY Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score |
0.04; -0.06 | 0.842 |
| SECONDARY Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score |
0.89; 0.75; -5.41; -1.69 | 0.417 |
| SECONDARY Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores |
1.91; -1.88; 1.09; -2.88 | 0.655 |
| SECONDARY Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score |
72.41; 82.49; 94.15; 94.89; 85.48; 86.03 | 0.580 |
Summary
This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Rheumatoid arthritis of >/= 1 year duration
- Mild to moderate disease activity at screening (DAS 28 2.6)
- On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
- Body weight </= 150 kg
- Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline
Exclusion Criteria
- 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 rheumatoid arthritis
- Functional class IV American College of Rheumatology (ACR) Classification
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- 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 tocilizumab
- Pregnant or lactating women
- Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
- History of or currently active primary or secondary immunodeficiency
- Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for HIV infection
Data sourced from ClinicalTrials.gov (NCT01587989). 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.