Newly 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
Conditions
Interventions
Trade Name: Salazopyrin En-Tabs
Product Name: salazopyrin EN
Pharmaceutical Form: Tablet
Trade Name: neoral
Pharmaceutical Form: Capsu
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare intensive management with standard care in terms of the proportion of patients achieving an ACR20 response at 48 weeks post-randomisation, in order to determine whether intensive management has superior clinical efficacy.;Primary end point(s): Proportion of study patients achieving an ACR 20 response at 48 weeks post-randomisation.; Secondary Objective: To compare intensive management with standard care in terms of: •Additional clinical efficacy outcomes at 24 and 48 weeks, including: ACR20 (24 weeks), ACR50 and ACR70 PASI 20, PASI 75 and PASI 90 Change in Sharp-van der Heijde Score ASAS 20 and ASAS 40 Change in enthesitis score Change in dactylitis score Change in mNAPSI Change in HAQ Change in other scores (including BASDAI, tender and swollen joint counts, patient and clinician VAS scores) MDA score • Comparison of Quality of Life (QoL),using PsAQoL between intensive management and standard care at baseline, 24 and 48 weeks • Assessment of cost effectiveness at 12, 24 and 48 weeks • Comparison of safety outcomes over the course of the treatment until 52 weeks • Comparison of imaging efficacy outcomes including change in Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) and ultrasound assessment of disease at 48 weeks in order to assess inflammation and damage. | — |
Countries
United Kingdom
Outcome results
None listed