Comparative Analysis of Two Therapeutic Strategies in Patients With Spondyloarthritis Treated With Anti-tnf Biologics (STRADA)

University Hospital, Rouen

Status and phase

Terminated

Phase 4

Conditions

Spondyloarthritis

Treatments

Biological: anti drug antibodies dosage

Study type

Interventional

Funder types

Other

Identifiers

NCT01971918

2013/006/HP

Details and patient eligibility

About

The objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-TNF definite by increase of ASDAS and positivity to ADAb.

Patients and Methods:

Multicentric randomized prospective study. Duration of inclusion 30 months. Duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their ADAb dosage is positive, and they will be randomized (1:1) in two groups : "early switch" where treatment will be change to another anti-TNF, or "therapeutic intensification" where interval between two injections will be shortened. Patients will be evaluated clinically (ASDAS) and biologically (ADAb) at 12 weeks then at 24 weeks. Principal outcome will be the variation of ASDAS between baseline and end of the study. Number of patients to be included has been determined statistically from a preliminary study (power >98% for ASDAS variation of 20% on week 24).

Expected results:

On week 24, we expect a better response and a greater proportion of patients in remission in the "early switch" arm compare to the "therapeutic intensification" arm.

Enrollment

8 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Spondyloarthritis positive for the ASAS criteria, treated with a first biologic : infliximab ( 5mg/kg intravenously every 8 weeks) or adalimumab (40mg subcutaneously every 2 weeks)
Active spondyloarthritis definite by ASDAS-CRP > 2.1 at two successive evaluations while patient was previously responder (ASDAS<2.1 at least once in the 6th months after beginning of treatment)
Positivity to anti-drug antibodies (ADAb)
Consent of the patient
No contra-indication to another anti-tnf biologic
affiliation to health insurance
woman of childbearing age must use an appropriate mean of contraception

Exclusion criteria

Pregnant or breastfeeding woman
contra-indication to anti-tnf biologic
patient with known hypersensitivity to any of the excipients
Severe and uncontrolled opportunistic infection , includins septicemia, tuberculosis, abcess and opportunistic infection
Evolutive infection, including chronic or localised infection
Patient with moderate to severe heart failure (NYHA class III/IV)