N/A
Completed N=566
A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece
Source: ClinicalTrials.gov NCT01086033 ↗Enrolled (actual)
566
Serious AEs
11.5%
Results posted
Sep 2013
Primary outcomePrimary: Number of Participants With Adverse Events — 262; 65 participants
Summary
The objectives of the study are to observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization and to observe compliance of patients with the prescribed treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
262; 65 | — |
| PRIMARY Disease Activity Score (DAS) 28 Over Time |
6.0; 4.2; 3.8; 3.5; 3.5; 3.3 | — |
| PRIMARY European League Against Rheumatism (EULAR) Response |
112; 242; 147; 154; 193; 96 | — |
| PRIMARY Number of Participants With an American College of Rheumatology (ACR) 20 Response |
265; 279; 263; 248; 241; 216 | — |
| PRIMARY Number of Participants With an American College of Rheumatology (ACR) 50 Response |
134; 188; 205; 182; 184; 170 | — |
| PRIMARY Number of Participants With an American College of Rheumatology (ACR) 70 Response |
67; 118; 147; 142; 154; 149 | — |
| SECONDARY Percentage of Participants Who Missed at Least One Dose of Humira |
6.6; 8.6; 7.4; 7.3; 8.2; 7.6 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving Humira (adalimumab) under normal clinical practice for at least one month prior to inclusion and according to the approved Summary of Product Characteristics (SPC) in the European Union.
- Patients must be willing to consent to data being collected and provided to Abbott Laboratories.
Exclusion Criteria
- Contraindications according to the SPC.
- Patients should not participate in another observational Abbott study.
Data sourced from ClinicalTrials.gov (NCT01086033). 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.