N/A
Completed N=155
Assessment of Pain Management in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Patients Who Are About to be Treated With Adalimumab
Source: ClinicalTrials.gov NCT01273519 ↗Enrolled (actual)
155
Serious AEs
1.9%
Results posted
Feb 2014
Primary outcomePrimary: Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 — 58.32; 34.28; 27.14; 21.71 units on a scale
Summary
The purpose of this study is to assess whether or not adalimumab (Humira®) can influence pain medication in participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) with or without comorbidities, which do not constitute a contraindication for adalimumab as stated in the released summary of product characteristics. Therefore it shall be evaluated if pain medication which is used in these participants is changed, reduced or stopped due to adalimumab treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 |
58.32; 34.28; 27.14; 21.71; 14.62 | — |
| PRIMARY Physician Assessment of Present Pain Intensity Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 |
56.55; 31.19; 25.32; 19.06; 12.2 | — |
| PRIMARY Participant Assessment of Present Pain Intensity Recorded on a Likert Scale at Baseline and Month 12 |
4; 49; 22; 40; 61; 14 | — |
| PRIMARY Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Visual Analogue Scale (VAS) at Baseline and Months 3, 6, 9, and 12 |
64.31; 38.24; 30.89; 24.74; 17.36 | — |
| PRIMARY Participant Assessment of Pain Intensity in the Past 3 Months Recorded on a Likert Scale at Baseline and Month 12 |
0; 40; 10; 44; 71; 19 | — |
| PRIMARY Participant Assessment of the Pattern of Pain Progression (Daytime/Nocturnal) in the Past 3 Months at Baseline and Month 12 |
41; 42; 18; 22; 26; 13 | — |
| PRIMARY Participant Assessment of the Pattern of Pain Progression (Sudden/Creeping) in the Past 3 Months at Baseline and Month 12 |
40; 30; 101; 56 | — |
| PRIMARY Participant Assessment of the Presence of Nocturnal Pain Progression in the Past 3 Months at Baseline and Month 12 |
3; 41; 14; 42; 57; 3 | — |
| PRIMARY Participant Assessment of the Presence of Distress Caused by Pain in the Last 3 Months Recorded on a Likert Scale at Baseline and Month 12 |
0; 33; 0; 23; 10; 28 | — |
| SECONDARY Mean Medical Outcomes Study Short Form 36 (SF-36) Summary of Scales at Baseline, and Months 3, 6, 9, and 12 |
46.9; 62.1; 66.9; 71.9; 77.1; 16.7 | — |
| SECONDARY Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores at Baseline, and Months 3, 6, 9, and 12 |
1.31; 0.85; 0.88; 0.94; 0.62; 0.75 | — |
| SECONDARY Mean Rheumatoid Arthritis Disease Activity Index (RADAI) at Baseline, and Months 3, 6, 9, and 12 |
5.46; 4.72; 4.61; 3.78; 2.41; 4.23 | — |
| SECONDARY Mean Bath Ankylosing Spondylitis Functional Index (BASFI) Scores at Baseline, and Months 3, 6, 9, and 12 |
5.46; 3.78; 2.74; 2.19; 1.72 | — |
| SECONDARY Mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for Participants With Ankylosing Spondylitis (AS) at Baseline, and Months 3, 6, 9, and 12 |
5.65; 3.24; 2.62; 1.97; 1.23 | — |
| SECONDARY Mean Erythrocyte Sedimentation Rate (ESR) at Baseline, and Months 3, 6, 9, and 12 |
32.87; 23.96; 28.58; 21.95; 13.4; 12.45 | — |
| SECONDARY Mean C-reactive Protein (CRP) at Baseline, and Months 3, 6, 9, and 12 |
1.83; 1.56; 1.18; 4.3; 2.31; 0.84 | — |
Eligibility Criteria
Inclusion Criteria
- Patients aged ≥ 18 years for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis
- Patients must fulfill international and national guidelines for the use of a biological disease modifying antirheumatic drug in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (chest x-ray and interferon gamma release assay or purified protein derivative-skin test negative for tuberculosis). In addition one of the following criteria must be fulfilled:
- unsatisfactory disease modifying antirheumatic drug response defined as failure to treatment with at least two disease modifying antirheumatic drugs including Methotrexate in patients with rheumatoid arthritis or psoriatic arthritis
- unsatisfactory non steroidal antiinflammatory drug response in patients with ankylosing spondylitis or unsatisfactory response to prior biological disease modifying antirheumatic drugs in patients with rheumatoid arthritis or psoriatic arthritis or ankylosing spondylitis
Exclusion Criteria
- Patients who meet contraindications as outlined in the latest version of the Humira syringe® summary of product characteristics and Humira Pen® summary of product characteristics
- Patients participating in another study program or clinical trial
- Patients who have been treated with Humira before
Data sourced from ClinicalTrials.gov (NCT01273519). 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.