Phase 3
Completed N=28
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF
Source: ClinicalTrials.gov NCT01326962 ↗Enrolled (actual)
28
Serious AEs
7.1%
Results posted
Mar 2016
Primary outcomePrimary: Disease Activity as Measured by Disease Activity Score 28 (DAS28) — 5.4; 3.5; 2.8; 2.2 units on a scale
◆ Published Evidence
Emerging
4citations · ~0 / year
Tocilizumab efficacy and safety in rheumatoid arthritis patients after inadequate response to disease-modifying anti-rheumatic drugs oranti-tumor necrosis factor.
Summary
This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.
Linked Publications
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Tocilizumab efficacy and safety in rheumatoid arthritis patients after inadequate response to disease-modifying anti-rheumatic drugs oranti-tumor necrosis factor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Activity as Measured by Disease Activity Score 28 (DAS28) |
5.4; 3.5; 2.8; 2.2; 1.9; 1.7 | — |
| PRIMARY Number of Participants Who Achieved Remission (DAS28 < 2.6) |
3; 7; 12; 14; 17; 16 | — |
| PRIMARY Time to Das28 Remission |
189.01 | — |
| PRIMARY Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units) |
21; 20; 20; 22; 21; 20 | — |
| PRIMARY Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2) |
7; 9; 7; 7; 4; 3 | — |
| PRIMARY Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response |
7; 6; 6; 7; 6; 4 | — |
| PRIMARY Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score |
23.5; 24.1; 23.6; 24.0; 21.6; 22.0 | — |
| PRIMARY Change in Fatigue as Measured Using the Fatigue Visual Analog Scale |
38.1; 32.3; 29.0; 20.1; 14.4; 18.0 | — |
| SECONDARY Number of Participants With Any Adverse Event and Serious Adverse Event |
4; 2 | — |
| SECONDARY Number of Participants With AE or SAE Related Discontinuation of Tocilizumab |
2 | — |
| SECONDARY Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response |
3; 4; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With C-Reactive Protein Abnormality |
16; 8; 7; 2; 5; 6 | — |
| SECONDARY Number of Participants With Erythrocyte Sedimentation Rate Abnormality |
13; 5; 3; 1; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Active moderate to severe rheumatoid arthritis of >/= 6 months duration
- >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any time prior to study treatment
- Inadequate clinical response to non-biologic DMARD or anti-TNF therapy
- Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug
Exclusion Criteria
- Pregnant or lactating women
- Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment
- Rheumatic autoimmune disease other than RA
- Functional class IV (ACR classification)
- Prior history of or current joint disease other than RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Previous treatment with RoActemra/Actemra
- 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
Data sourced from ClinicalTrials.gov (NCT01326962) 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.