N/A
N=76
Good EULAR Response In Patients With Early Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01558089 ↗Enrolled (actual)
76
Serious AEs
7.9%
Results posted
Nov 2016
Primary outcome: Primary: Primary: Participants With EULAR (Good) — 19 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- etanercept (Drug); methotrexate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary: Participants With EULAR (Good) |
19 | — |
| SECONDARY Change From Baseline in Tender Joint Count at Visit 4 (Month 6) |
-7.68 | — |
| SECONDARY Change From Baseline in Swollen Joint Count at Visit 4 (Month 6) |
-4.52 | — |
| SECONDARY Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6) |
-38.14 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6) |
-21.21 | — |
| SECONDARY Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6) |
0.40 | — |
| SECONDARY Change From Baseline in HAQ-DI at Visit 4 (Month 6) |
-0.78 | — |
| SECONDARY Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF) |
2.831 | — |
Summary
This open-label, prospective, observational study will evaluate the clinical response to etanercept + methotrexate therapy in patients with moderate to severe rheumatoid arthritis, as prescribed by the rheumatologist in a normal clinical setting in Greece
Eligibility Criteria
Inclusion Criteria
- signed and dated informed consent document
- 18 years of age and older at the time of consent
- Patients with moderate-to-severe active rheumatoid arthritis, who satisfy the 2010 Rheumatoid Arthritis Classification Criteria
- Patients who have been prescribed for first time to receive treatment with MTX + Etanercept prior to enrollment to this study, following routine clinical practice and according to the approved SmPC,
- Patients with DAS28 ≥ 3.2
- Duration of disease symptoms ≥ 6 weeks and ≤2 years
- Failure to respond to prior DMARDs including MTX monotherapy according to routine clinical practice.
Exclusion Criteria
- Contraindications according to the SmPC
- History of or present anti-TNFa or other biologic therapy for the treatment of RA
- Known significant concurrent medical disease according to investigator's opinion and the current SmPC
Data sourced from ClinicalTrials.gov (NCT01558089). 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.