A randomised controlled single-blind trial to compare intensive management vs standard care in early psoriatic arthritis - TICOPA

Phase 1

• Conditions: ewly diagnosed psoriatic arthritis of less than two years symptom duration; MedDRA version: 14.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2007-004757-28-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-14
• Study Completion: 2013-05-10
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 206

Inclusion Criteria

Patients with the following characteristics are eligible for the study:
1.Patients with a diagnosis of psoriatic arthritis by a consultant Rheumatologist with less than 24 months disease duration.
2.Active disease defined by at least one tender or swollen joint or active enthesitis.
3.Age =18 years at the time of signing the informed consent form and either male or female patients.
4.Patient understands the objectives of the study and is able and willing to sign the Informed Consent Form.
5.Men and women of child bearing potential (WCBP) must use at least one adequate birth control measure for the duration of the study and should continue such precautions for 6 months after receiving the last dose of protocol treatment.
6.Adequate full blood count within 28 days before randomisation:
a.Haemoglobin count > 8.5 g/dL
b.White blood count (WBC) > 3.5 x 109/L
c.Absolute neutrophil count (ANC) > 1.5 x 109/L
d.Platelet count > 100 x 109/L
7.Adequate hepatobiliary function within 28 days before randomisation:
a. ALT and/or AST levels must be within 3 times the upper limit of normal range (ULN) for the laboratory conducting the test.
8.The patient must be able to adhere to the study visit schedule and other protocol requirements.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from this study for any of the following reasons:
1.Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazone, leflunomide,
2.Women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment.
3.Use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation.

Study & Design

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