N/A
Completed N=4,208
Efficacy and Safety of Adalimumab in Patients With Rheumatoid Arthritis in Routine Clinical Practice
Source: ClinicalTrials.gov NCT01077258 ↗Enrolled (actual)
4,208
Serious AEs
5.8%
Results posted
Apr 2014
Primary outcomePrimary: Change From Baseline in Disease Activity Score (DAS) 28 — -1.5; -1.8; -1.9; -2.0 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 2 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score (DAS) 28 |
-1.5; -1.8; -1.9; -2.0; -2.1; -2.2 | — |
| PRIMARY Percentage of Participants in DAS28 Remission |
18.1; 22.0; 26.1; 27.2; 29.8; 34.6 | — |
| SECONDARY Percentage of Participants With a Significant Therapeutic Response |
38.9; 49.1; 54.7; 56.3; 60.1; 61.9 | — |
| SECONDARY Percentage of Participants With Low, Moderate and High Disease Activity |
0.0; 30.2; 36.5; 41.8; 43.7; 46.7 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) Over Time |
32.1; 23.2; 22.1; 21.6; 21.4; 21.0 | — |
| SECONDARY C-Reactive Protein (CRP) Levels Over Time |
20.0; 11.9; 9.2; 8.1; 8.0; 6.6 | — |
| SECONDARY Tender Joint Count (TJC) Over Time |
10.6; 5.4; 4.3; 3.9; 3.6; 3.4 | — |
| SECONDARY Swollen Joint Count (SJC) Over Time |
7.7; 3.7; 3.0; 2.6; 2.4; 2.1 | — |
| SECONDARY Hannover Functional Questionnaire (FFbH) Over Time |
61.9; 68.4; 70.4; 71.3; 71.9; 72.4 | — |
| SECONDARY Patients Global Assessment of Disease Activity Over Time |
6.3; 4.7; 4.4; 4.2; 4.1; 4.0 | — |
| SECONDARY Participants Assessment of Fatigue Over Time |
5.8; 4.5; 4.2; 4.0; 4.0; 3.9 | — |
| SECONDARY Participants Assessment of Pain Over Time |
6.4; 4.5; 4.2; 4.1; 3.9; 3.9 | — |
| SECONDARY Percentage of Participants With Impairment in Daily Activities |
19.7; 35.8; 40.3; 45.7; 51.4; 52.1 | — |
| SECONDARY Number of Days Missed From Work Due to Rheumatoid Arthritis |
20.6; 9.9; 4.4; 5.2; 3.8 | — |
| SECONDARY Percentage of Participants With In-patient Hospitalization |
21.6; 7.2; 5.8; 5.4; 3.6 | — |
| SECONDARY Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication |
54.0; 52.3; 53.2; 53.1; 53.2; 52.9 | — |
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, Humira 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 (NCT01077258). 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.