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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 26 June 2012
Main ID:  EUCTR2008-006885-27-NL
Date of registration: 05/11/2008
Prospective Registration: Yes
Primary sponsor: Clinical Immunology and Rheumatology
Public title: EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS
Scientific title: EFFICACY AND SAFETY OF ADALIMUMAB (HUMIRA®) IN PATIENTS WITH PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS
Date of first enrolment: 21/04/2009
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006885-27
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: first 12 wks: randomised, double-blind, placebo-controlled; last 12 wks: open label extension If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Phase: 
Countries of recruitment
Netherlands
Contacts
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Key inclusion & exclusion criteria
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
PERIPHERAL SPONDYLOARTHRITIS WITHOUT ANKYLOSING SPONDYLITIS OR PSORIATIC ARTHRITIS
MedDRA version: 9.1 Level: LLT Classification code 10051265 Term: Spondyloarthropathy
Intervention(s)

Trade Name: Humira
Product Name: adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
CAS Number: na
Current Sponsor code: na
Other descriptive name: ADALIMUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)
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.
Primary end point(s): Efficacy: Patient’s Global Assessment of Disease at week 12
Safety: detailled questionaire for adverse events, clinical examination, laboratory evaluation (hematology, chemistry, urine analysis)
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.
Secondary Outcome(s)
Secondary ID(s)
ADA-periSPA2008
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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