TIght COntrol of Psoriatic Arthritis

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether tight control of patients with newly diagnosed psoriatic arthritis (consisting of regular 4 weekly objective assessment of disease activity and protocol-led intensive treatment) can improve outcome as opposed to standard care (usually 3 monthly reviews with no objective outcome measures and no protocol for treatment). The principle hypothesis of this study is that tight control of inflammation in psoriatic arthritis using a treatment protocol and pre-defined objective targets for treatment will lead to an improvement in patients' disease activity and a reduction in radiological joint damage.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Julia Brown
• Collaborators: Arthritis Research UK; Pfizer

Criteria

Inclusion Criteria:

• Patients with a diagnosis of psoriatic arthritis by a consultant Rheumatologist with less than 24 months disease duration.

• Active disease defined by at least one tender or swollen joint or active enthesitis.

• Age ≥18 years at the time of signing the informed consent form and either male or female patients.

• Patient understands the objectives of the study and is able and willing to sign the Informed Consent Form.

• 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.

• Adequate full blood count within 28 days before randomisation:

• Haemoglobin count > 8.5 g/dL

• White blood count (WBC) > 3.5 x 10*9/L

• Absolute neutrophil count (ANC) > 1.5 x 10*9/L

• Platelet count > 100 x 10*9/L

• Adequate hepatobiliary function within 28 days before randomisation:

*ALT and/or AST levels must be within 3 times the upper limit of normal range (ULN) for the laboratory conducting the test.

• The patient must be able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

• Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide,

• Women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment.

• Use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation.