Efficacy and safety of adalimumab in patients with peripheral spondyloarthritis without ankylosing spondylitis or psoriatic arthritis.
- Conditions
- spondyloarthritis - spondyloarthropathy1000381610023213
- Registration Number
- NL-OMON32839
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
1. Prior to any study procedure, voluntary written informed consent must be obtained, after the nature and purpose of this study are explained
2. Patients should be between 18 and 70 years of age
3. Patients must have a diagnosis of peripheral spondyloarthritis not fulfilling the classification criteria for ankylosing spondylitis or psoriatic arthritis for at least 3 months. The disease must be moderate to severely active as defined by at least 1 swollen and at least 1 tender or painful joints
4. If female, patient should either be of not-childbearing potential (i.e. postmenopausal or surgically sterile) or practice a reliable method of birth control until 150 days post-study (e.g. use of condom, IUD, oral contraceptives) or have a vasectomized partner
5. Patients should have inadequate response to NSAID therapy (non-steroidal, anti-inflammatory drugs)
6. The use of concomitant NSAIDs and corticosteroids is allowed. The dose of corticosteroids should not exceed a prednisone equivalent * 10 mg/day and must be stable for at least 4 weeks prior to baseline
7. The use of concomitant DMARDs (disease modifying anti-rheumatic drugs, Methotrexaat or Sulphasalazine) is allowed. If using DMARDs, patients must have received a minimum of 3 months of therapy and be on a stable dose for at least 4 weeks prior to baseline
8. Patients are considered to be in generally good health based upon the result of a medical history, physical examination, laboratory profile, chest X-ray and ECG
1. Patient has previously received anti-TNF therapy or another investigational drug in the past 2 months
2. Patient has received an intra-articular injection with corticosteroids within 4 weeks prior to baseline
3. Patient has an active articular disease (other than peripheral spondyloarthritis not fulfilling the classification criteria for ankylosing spondylitis or psoriatic arthritis) that could interfere with the assessment of arthritis
4. Patient has a history of active tuberculosis. A PPD test and chest X-ray done at screening should be negative (in case of latent tuberculosis, a patient may enter the study if prophylaxis with isoniazide is begun prior to administration of adalimumab)
5. Patients has a recent history of (or persistent) infection requiring hospitalization or antibiotic treatment within 4 weeks of baseline
6. Patient has a significant history of cardiac, renal, neurological, metabolic or any other disease that may affect his/her participation in this study
7. Patient has a history of malignancy (other than basal cell carcinoma of the skin) in the past 10 years
8. If female, patient should not be pregnant or breast-feeding. A serum pregnancy-test will be performed at screening has to be negative
9. Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy: Patient*s Global Assessment of Disease at week 12<br /><br>Safety: detailled questionaire for adverse events, clinical examination,<br /><br>laboratory evaluation (hematology, chemistry, urine analysis)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy: Patient's Global Assessment of Disease at week 24, Physician*s Global<br /><br>Assessment of Disease, BASDAI, number of swollen and tender joints, CRP and ESR<br /><br>Serum biomarkers: MMP3, MRP8/14, cartilage and bone biomarkers, autoantibodies<br /><br>Synovial biomarkers: celinfiltration, cytokine expression, MMP expression,<br /><br>vascularisation<br /><br>Function and quality of life: Health Assessment Questionnaire; AMC Linear<br /><br>Disability Score; HUI-3</p><br>