N/A
Completed N=5,745
Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice
Source: ClinicalTrials.gov NCT01078090 ↗Enrolled (actual)
5,745
Serious AEs
2.8%
Results posted
Apr 2014
Primary outcomePrimary: Change From Baseline in Disease Activity Score (DAS) 28 — -1.6; -1.8; -2.0; -2.1 units on a scale
Summary
Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score (DAS) 28 |
-1.6; -1.8; -2.0; -2.1; -2.2; -2.3 | — |
| PRIMARY Percentage of Participants in DAS28 Remission |
12.8; 16.9; 19.4; 23.0; 23.3; 24.3 | — |
| SECONDARY Percentage of Participants With a Significant Therapeutic Response |
40.8; 50.5; 53.6; 58.7; 60.3; 63.3 | — |
| SECONDARY Percentage of Participants With Low, Moderate and High Disease Activity |
0.0; 23.9; 29.8; 33.0; 38.7; 38.5 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) Over Time |
34.5; 24.7; 23.8; 22.8; 22.0; 21.6 | — |
| SECONDARY C-Reactive Protein (CRP) Levels Over Time |
33.7; 19.8; 16.1; 17.0; 14.9; 12.3 | — |
| SECONDARY Tender Joint Count (TJC) Over Time |
12.3; 6.4; 5.4; 4.9; 4.4; 4.2 | — |
| SECONDARY Swollen Joint Count (SJC) Over Time |
9.5; 4.7; 3.9; 3.5; 3.1; 2.7 | — |
| SECONDARY Hannover Functional Questionnaire (FFbH) Over Time |
57.7; 65.1; 67.1; 68.3; 69.4; 69.9 | — |
| SECONDARY Patients Global Assessment of Disease Activity Over Time |
6.6; 4.8; 4.5; 4.3; 4.1; 4.1 | — |
| SECONDARY Participants Assessment of Pain Over Time |
6.8; 4.7; 4.3; 4.1; 3.9; 3.9 | — |
| SECONDARY Participants Assessment of Fatigue Over Time |
6.0; 4.5; 4.2; 4.0; 3.8; 3.8 | — |
| SECONDARY Percentage of Participants With Impairment in Daily Activities |
17.9; 38.8; 45.8; 44.5; 45.2; 28.2 | — |
| SECONDARY Number of Days Missed From Work Due to Rheumatoid Arthritis |
51.0; 11.6; 8.6; 6.8; 4.9; 5.2 | — |
| SECONDARY Percentage of Participants With In-patient Hospitalization |
27.6; 10.9; 7.4; 6.7; 6.4; 5.3 | — |
| SECONDARY Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication |
54.0; 51.9; 52.2; 54.4; 53.9; 54.8 | — |
Eligibility Criteria
Inclusion Criteria
- Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate.
- Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before.
- In case of incompatibility with methotrexate, adalimumab can be used as monotherapy
Exclusion Criteria
- Hypersensitivity against the drug or one of the other ingredients; active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections); moderate to severe cardiac insufficiency
Data sourced from ClinicalTrials.gov (NCT01078090). 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.