Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

SPEED is a three arm interventional trial nested within a cohort (Trials Within Cohorts or TWiCs design). This tests more aggressive early therapy in patients newly diagnosed with moderate to severe PsA. Arm 1 will receive standard step up therapy in the cohort and act as the control group. Arm 2 will receive early combination conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs). Arm 3 will receive early tumour necrosis factor (TNF) inhibitor therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Treatments: Adalimumab; Leflunomide; Methotrexate; Sulfasalazine

Criteria

Inclusion Criteria:

• Participant is willing and able to give informed consent for participation in the trial.

• Male or Female, aged 18 years or above.

• Participants consented to the PsA inception cohort (MONITOR-PsA) and to be approached for alternate interventional therapies.

• Poor prognostic factors at baseline. Either

• Polyarticular disease with ≥5 active joints at baseline assessment OR

• Oligoarticular disease with <5 active joints at baseline but with one or more of the following poor prognostic factors: raised C reactive protein, radiographic damage, health assessment questionnaire>1

• Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter (or 2 years if received leflunomide unless treated with washout therapy) as in standard practice.

• Participant has clinically acceptable laboratory results within 28 days of baseline:

• Haemoglobin count > 8.5 g/dL

• White blood count (WBC) > 3.5 x 109/L

• Absolute neutrophil count (ANC) > 1.5 x 109/L

• Platelet count > 100 x 109/L

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase levels <3 x upper limit of normal

• In the Investigator's opinion, is able and willing to comply with all trial requirements.

• Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the trial.

Exclusion Criteria:

• Previous treatment for articular disease with DMARDs including, but not limited to, methotrexate, sulfasalazine, leflunomide and ciclosporin

• Female patient who is pregnant, breast-feeding or planning pregnancy during the course of the trial.

• Significant renal (estimated glomerular filtration rate <30ml/min) or hepatic impairment.

• Patients who test positive for Hepatitis B, C or HIV.

• Contraindication to any of the investigative drugs.

• Patients who currently abuse drugs or alcohol

• Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.

• Patient with life expectancy of less than 6 months.

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put patients at risk because of participation in the trial, or may influence the result of the trial, or their ability to participate in the trial.

• Participation in another research trial involving an investigational product in the past 12 weeks.

Additional exclusion criteria apply to patients randomised to arm 3 and receiving adalimumab therapy:

• Active tuberculosis (TB), chronic viral infections, recent serious bacterial infections, those receiving live vaccinations within 3 months of the anticipated first dose of study medication, or those with chronic illnesses that would, in the opinion of the investigator, put the participant at risk.

• Latent TB unless they have received appropriate anti-tuberculous treatment as per local guidelines

• History of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.