Severe Psoriatic arthritis – Early intervEntion to control Disease: the SPEED trial
- Conditions
- MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Psoriatic Arthritis
- Registration Number
- EUCTR2017-004542-24-GB
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 315
•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 REC Ref 17/SC/0556) and to be approached for alternate interventional therapies.
•Poor prognostic factors at baseline. Either
oPolyarticular disease with =5 active joints at baseline assessment OR
oOligoarticular 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:
oHaemoglobin count > 8.5 g/dL
oWhite blood count (WBC) > 3.5 x 109/L
oAbsolute neutrophil count (ANC) > 1.5 x 109/L
oPlatelet count> 100 x 109/L
oAST or 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 GP and consultant, if appropriate, to be notified of participation in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
•Previous treatment for articular disease with disease modifying drugs (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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method