N/A
Completed N=163
Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents
Source: ClinicalTrials.gov NCT01783730 ↗Enrolled (actual)
163
Serious AEs
2.6%
Results posted
Oct 2016
Primary outcomePrimary: Number of Participants With Adverse Events — 40 participants
Summary
This study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
40 | — |
| SECONDARY Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline |
5.61 | — |
| SECONDARY Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4 |
3.57 | — |
| SECONDARY Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12 |
2.96 | — |
| SECONDARY Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24 |
2.41 | — |
| SECONDARY Percentage of Participants Achieving DAS28-4(ESR) Remission |
0.0; 29.9; 45.6; 60.8 | — |
| SECONDARY Mean Clinical Disease Activity Index (CDAI) Score at Baseline |
29.18 | — |
| SECONDARY Mean Clinical Disease Activity Index (CDAI) Score at Week 4 |
10.95 | — |
| SECONDARY Mean Clinical Disease Activity Index (CDAI) Score at Week 12 |
7.26 | — |
| SECONDARY Mean Clinical Disease Activity Index (CDAI) Score at Week 24 |
3.96 | — |
| SECONDARY Percentage of Participants Achieving CDAI Remission |
0.7; 20.0; 35.2; 60.2 | — |
| SECONDARY Mean Simplified Disease Activity Index (SDAI) Score at Baseline |
32.30 | — |
| SECONDARY Mean Simplified Disease Activity Index (SDAI) Score at Week 4 |
12.06 | — |
| SECONDARY Mean Simplified Disease Activity Index (SDAI) Score at Week 12 |
8.08 | — |
| SECONDARY Mean Simplified Disease Activity Index (SDAI) Score at Week 24 |
4.58 | — |
| SECONDARY Percentage of Participants Achieving SDAI Remission |
0.0; 22.0; 39.8; 58.8 | — |
Eligibility Criteria
Inclusion Criteria
- High disease activity, with poor prognostic factors (e.g., rheumatoid factor [RF]-positive, anti-cyclic citrullinated peptide [CCP] antibody-positive, or bone erosion)
- Combination of adalimumab and methotrexate will be started
- No prior history of treatment with disease-modifying anti-rheumatic drugs
- No prior history of treatment with biological agents
- Adalimumab dosed according to the registered product label
- Signed informed consent
Exclusion Criteria
There were no specific exclusion criteria.
Data sourced from ClinicalTrials.gov (NCT01783730). 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.