Phase 4
N=203
RESTART C0168Z05 Rheumatoid Arthritis Study
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00714493 ↗Enrolled (actual)
203
Serious AEs
4.9%
Results posted
Feb 2011
Primary outcome: Primary: Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10 — 49.7 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Infliximab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centocor Ortho Biotech Services, L.L.C.
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10 |
49.7 | — |
| SECONDARY Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase |
22.3 | — |
| SECONDARY Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26 |
51.8 | — |
| SECONDARY Change From Baseline in Physical Function (HAQ) |
-0.223 | <0.001 sig |
| SECONDARY Change From Baseline in Physical Function (HAQ) |
-0.223 | <0.001 sig |
| SECONDARY Percent of Patients Who Achieved ACR20 at Week 10 |
28.4 | — |
| SECONDARY Percent of Patients Who Achieved ACR20 at Weeks 26. |
35.5 | — |
Summary
The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.
Eligibility Criteria
Inclusion Criteria
- Patients must have rheumatoid arthritis
- Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
- Patients must have inadequate disease response to etanercept or adalimumab
- Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.
Exclusion Criteria
- Patients who have a history of latent or active TB
- Have inflammatory disease other than rheumatoid arthritis
- Have had a chronic or recurrent infectious disease.
Data sourced from ClinicalTrials.gov (NCT00714493). 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.