ail involvement in psoriatic arthritis: a cross-sectional and observational prospective study.

• Conditions: psoriatic artritis; MedDRA version: 13.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-000699-32-BE
• Lead Sponsor: Z KULeuven, service of Rheumatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-18
• Last Update Posted: 18 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Part 1:
-PsA patients must meet the CASPAR criteria
-Psoriasis patients must meet criteria for psoriasis
-RA patients must meet the 1987 revised ACR criteria for RA
-Hand OA patients must meet the ACR criteria for hand OA.
-Healthy controls

Part 2
-Diagnosis of psoriatic arthritis fulfilling the CASPAR criteria
-Polyarticular disease (> 5 joints)
-Active arthritis in at least 5 joints
-Active disease despite adequate methotrexate treatment.
-Health Assesment Questionnaire index of 25%.
-Current nail disease including onycholysis, pitting, and hyperkeratosis observed on current physical examination in at least 2 finger nails.
-Gender: males and females
-Age: 18 to 80 years of age.
-Patients are considered eligible according to the tuberculosis (TB) eligibility assessment, screening, and early detection of reactivation rules
-Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
-Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
-Within 1 month prior to the first administration of study agent, either have a negative tuberculin skin test, as outlined in Appendix 4, or have a newly identified positive tuberculin skin test during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated prior to the first administration of study agent
-Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB
-The screening laboratory test results must meet the following criteria:
oWBC (white blood cell count): 3.000 to 10.000/ml
oANC (absolute neutrophil count): > 500/ml
oHemoglobin:12-16 mg/dl (females) – 14-18 mg/dl (males)
oPlatelets: 150-450 * 109/l
oSerum Creatinine: 0,5 – 1,2 mg/dl
oSGOT (AST – aspartate aminotransferase) - < 2times upper normal limit
oSGPT (ALT – alanine aminotransferase) < 2times upper normal limit
oAlkaline phosphatase < 2times upper normal limit
oUA (urinalysis) with microscopic exam

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Part1
1. in the psoriasis group: patients with a history of or active joint disease
2. In the RA en OA groep: patients with psoriasis or a history hereof and with other nail diseases
3. In the healthy control group: presence or history of psoriasis or nail diseases.
Part2
1. Previous or current use of anti-TNF therapy or any other biologic.
2. Current use of cyclosporine or leflunomide.
3. If patients are using methotrexate, they must be on a stable dose for at least 3 months to be included in the study.
4. If patients are using corticosteroids, they must remain on a stable dose for at least 3 months of 10 mg or less of prednisolone (or equivalent) to be included in the study.
5. Nail or finger steroid applications including nail bed injections are forbidden during the study.
6. Treatment with UVA/PUVA, nitroglyceride ointment as well as cyclosporin or new biologics for psoriasis are not permitted.
7. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion).
8. Have had any previous treatment with monoclonal antibodies or antibody fragments.
9. History of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an exclusion criterion
10. Documentation of seropositive for human immunodeficiency virus (HIV).
11. Documentation of a positive test for hepatitis B surface antigen or hepatitis C.
12. Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results.
13. Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
14. Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
15. Are considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules defined in Section on: Tuberculosis Eligibility Assessment, Screening, and Early Detection of Reactivation Rules
16. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening.
17. Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening.
18. Have a chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB as described in Attachment D
19. Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly.
20. Currently have any known malignancy other than the condition being treated or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
21. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified