Table 1

TICOPA Study inclusion and exclusion criteria
Inclusion criteria
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. Women of child bearing potential (WCBP) and men whose partners are WCBP must use at least one adequate birth control measure whilst receiving protocol treatment and should continue such precautions after receiving the last dose of protocol treatment as indicated in the relevant SmPC.
6. Adequate full blood count within 28 days before randomisation:
a. Haemoglobin count > 8.5 g/dL
b. White blood count (WBC) > 3.5 × 109/L
c. Absolute neutrophil count (ANC) > 1.5 × 109/L
d. Platelet count > 100 × 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.
Exclusion criteria
1. Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, 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.

Coates et al.

Coates et al. BMC Musculoskeletal Disorders 2013 14:101   doi:10.1186/1471-2474-14-101

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