Phase 4
N=201
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00996203 ↗Enrolled (actual)
201
Serious AEs
6.0%
Results posted
Jul 2014
Primary outcome: Primary: Health Assessment Questionnaire (HAQ) Score — 1.93; 1.49; 1.22; 1.08 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tocilizumab [RoActemra/Actemra] (Drug); DMARDs (disease-modifying antirheumatic drugs) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Health Assessment Questionnaire (HAQ) Score |
1.93; 1.49; 1.22; 1.08; 1.00; 0.90 | — |
| PRIMARY Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment |
51.8; 15.6; 5.0; 72.2; 28.8; 13.6 | — |
| PRIMARY Change in HAQ Score at Week 24 |
1.11 | <0.001 sig |
| SECONDARY Pain Score as Assessed by Visual Analogue Scale (VAS) |
63.82; 46.36; 36.48; 31.90; 26.92; 24.63 | — |
| SECONDARY European Quality of Life - 5 Dimensions (EQ-5D) Score |
0.29; 0.49; 0.57; 0.61; 0.64; 0.66 | — |
| SECONDARY Change in EQ-5D Score at Week 24 From Baseline |
0.41 | <0.001 sig |
| SECONDARY General Health Score as Assessed by EQ-5D VAS |
39.27; 50.93; 61.79; 66.13; 70.48; 73.31 | — |
| SECONDARY Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D |
42.9; 55.6; 60.2; 65.8; 68.4; 73.1 | — |
| SECONDARY Change in General Health Assessed by VAS |
37.3 | <0.001 sig |
| SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28) |
6.748; 4.665; 3.777; 3.347; 2.956; 2.762 | — |
| SECONDARY Change in DAS28 Score From Baseline to Week 24 |
4.097 | <0.001 sig |
| SECONDARY Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment |
2.5; 97.5; 3.0; 9.6; 52.8; 34.5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response |
50.2; 76.1; 81.1; 89.6; 91.0; 89.1 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 |
15.9; 72.3; 11.8; 5.7; 61.9; 32.5 | — |
| SECONDARY C-Reactive Protein |
33.51; 8.67; 7.62; 5.43; 4.66; 4.92 | — |
| SECONDARY Erythrocyte Sedimentation Rate |
53.33; 15.29; 11.97; 10.00; 11.63; 10.71 | — |
Summary
This open-label single arm study will evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.
Eligibility Criteria
Inclusion Criteria
- adult patients, >/= 18 years of age
- moderate to severe active rheumatoid arthritis of >/=6 months duration
- inadequate clinical response to current non-biologic DMARDs
- current DMARDs must be at stable dose for 8 weeks prior to study entry
- oral corticosteroids ( /=4 weeks prior to screening
Exclusion Criteria
- rheumatic autoimmune disease other than RA
- history of or current inflammatory joint disease other than RA
- previous treatment with any biologic DMARD
- functional class IV as defined by the ACR classification
- intra-articular or parenteral corticosteroids within 6 weeks prior to screening
Data sourced from ClinicalTrials.gov (NCT00996203). 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.