EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS

Active, not recruiting

• Conditions: PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS; MedDRA version: 9.1Level: LLTClassification code 10051265Term: Spondyloarthropathy

• Registration Number: EUCTR2008-006885-27-NL
• Lead Sponsor: Clinical Immunology and Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-05
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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 AS or PsA (see appendix 1) for at least 3 months. The disease must be moderate to severely active as defined by ? 1 swollen and ? 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
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 (methotrexate or sulphalazine) 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be considered ineligible for study participation is any of the following criteria are met:
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 AS or PsA) 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the efficacy and safety of adalimumab for the treatment of peripheral spondyloarthritis not fulfilling the classification criteria for ankylosing spondylitis or psoriatic arthritis.;Secondary Objective: The secondary objectives of this study are to assess the effect of adalimumab on (i) function and quality of life, (ii) serum biomarkers, and (iii) synovial biomarkers.;Primary end point(s): Efficacy: Patient’s Global Assessment of Disease at week 12<br>Safety: detailled questionaire for adverse events, clinical examination, laboratory evaluation (hematology, chemistry, urine analysis)