EUCTR2013-000643-40-PT
Active, not recruiting
Phase 1
A multicentre, randomized, double-blind, parallel–group study to compare the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy, in improving dactylitis and enthesitis, in MTX naïve psoriatic arthritis patients - GO-DACT
ConditionsPsoriatic arthritisMedDRA version: 18.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsSimponi
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Psoriatic arthritis
- Sponsor
- Instituto de Medicina Molecular
- Enrollment
- 136
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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