EUCTR2007-004757-28-GB
Active, not recruiting
Phase 1
A randomised controlled single-blind trial to compare intensive management vs standard care in early psoriatic arthritis - TICOPA
niversity of Leeds0 sites206 target enrollmentMarch 14, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ewly diagnosed psoriatic arthritis of less than two years symptom duration
- Sponsor
- niversity of Leeds
- Enrollment
- 206
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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