Mechanism of action study of Ustekinumab treatment in psoriatic arthritis

• Conditions: psoriatic arthritis; MedDRA version: 17.1Level: LLTClassification code 10066579Term: Progression of psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 17.1Level: LLTClassification code 10066730Term: Recurrent psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 17.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 17.1Level: LLTClassification code 10003377Term: Arthropathy psoriaticSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 17.1Level: LLTClassification code 10037161Term: Psoriatic arthritis aggravatedSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 17.1Level: PTClassification code 10037162Term: Psoriatic arthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 17.1Level: HLTClassification code 10037163Term: Psoriatic arthropathiesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 17.1Level: LLTClassification code 10037166Term: Psoriatic spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-003148-11-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-26
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

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

Inclusion Criteria

-Psoriatic arthritis according to CASPAR criteria
- Active disease defined as: Swollen Joint count =3 and Tender Joint count =3
-Presence of knee and/or ankle arthritis in order to get synovial tissue biopsies

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 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Previous use of il-17 blocking therapy or multiple use of tnf-blocking therapies
-Contra-indication for needle arthroscopy such as joint replacement and anti-coagulation use.

Study & Design

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