Golimumab efficacy in psoriatic arthritis patients with active dactylitis

Phase 1

• Conditions: Psoriatic arthritis; MedDRA version: 18.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-000643-40-PT
• Lead Sponsor: Instituto de Medicina Molecular

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-24
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 136

Inclusion Criteria

Patients older than18 years, with the diagnosis of PsA according to CASPAR criteria, established at least 3 months prior to screening, with tender dactylitis, refractory to at least two systemic NSAIDs, at optimal dosage, for 3 months.
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 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

Exclusion criteria are those considered for any antiTNF agent and MTX or that might interfere with trial evaluations or patient’s safety.

Study & Design

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