Phase 4
Completed N=145
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS
Source: ClinicalTrials.gov NCT01149057 ↗Enrolled (actual)
145
Serious AEs
24.8%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population — 21.2; 5.4 units on a scale — p=<0.0001
Summary
This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population |
21.2; 5.4 | <0.0001 sig |
| PRIMARY Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population |
6.7 | <0.0001 sig |
| PRIMARY Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population |
7.1 | <0.0001 sig |
| PRIMARY Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population |
7.3 | <0.0001 sig |
| PRIMARY Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population |
20.9; 5.0 | <0.0001 sig |
| PRIMARY Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population |
6.8 | <0.0001 sig |
| PRIMARY Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population |
7.3 | <0.0001 sig |
| PRIMARY Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population |
7.3 | <0.0001 sig |
| SECONDARY Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study |
-0.81; -0.05; -1.13; 0.04; -0.67; 0.10 | 0.3778 |
| SECONDARY Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96 |
35; 37; 27; 33 | — |
| SECONDARY Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96 |
30.4; 38.9; 37.0; 45.8 | — |
| SECONDARY Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96 |
94.8; 94.7; 90.4; 94.5 | — |
| SECONDARY Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 |
10.3; 41.1; 11.6; 39.5; 16.7; 51.7 | — |
| SECONDARY Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 |
6.7; 37.5; 9.3; 36.1; 10.7; 42.7 | — |
| SECONDARY Change From Baseline in TJC At Weeks 24, 48, 72, and 96 |
22.8; -13.4; -15.2; -13.9; -14.5 | <0.0001 sig |
| SECONDARY Change From Baseline in SJC At Weeks 24, 48, 72, and 96 |
11.0; -7.3; -7.3; -7.6; -7.8 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 |
48.8; 63.5; 60.5; 58.0; 24.8; 28.1 | — |
| SECONDARY Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96 |
12.4; 0.7; 1.2; 1.0; 1.2 | — |
| SECONDARY C-reactive Protein Level |
2.8; 0.3; 0.3; 0.2; 0.3; 0.2 | — |
| SECONDARY Erythrocyte Sedimentation Rate |
45.3; 10.6; 11.3; 8.8; 9.8; 8.3 | — |
| SECONDARY Participant Assessment of Pain (VAS) |
70.3; 51.6; 53.0; 49.4; 44.7; 46.3 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96 |
1.8; -0.4; -0.4; -0.4; -0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 years of age
- Active moderate to severe rheumatoid arthritis
- Inadequate response to >/=3 DMARDs (non-biologic and/or biologic)
- Current treatment at stable dose for >/=8 weeks
- Etanercept discontinued >/=2 weeks, Anakinra >/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab >/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab >/=16 weeks, and must have proven B-cell repletion
Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
- Rheumatic autoimmune disease other than RA
- Functional class IV (American College of Rheumatology Classification)
- Prior history or current inflammatory joint disease other than RA
- Oral corticosteroids at a dose of >10 mg/day prednisone equivalent
- Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
- Current or history of recurrent bacterial, viral, fungal or mycobaterial infection
- History of or currently active primary or secondary immunodeficiency
Data sourced from ClinicalTrials.gov (NCT01149057). 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.