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

Comparative Analysis of Two Therapeutic Strategies: "Early Switch" Versus "Therapeutic Intensification" in Patients With Spondyloarthritis Treated With Anti-tnf Biologics, in Case of Secondary Treatment Failure Suspicion.

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.

Study Overview

• Status: Terminated
• Conditions: Spondyloarthritis
• Intervention / Treatment: Biological: anti drug antibodies dosage

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France, 60
    • UH Amiens
  • Caen, France, 14000
    • UH Caen
  • Dieppe, France, 76202
    • Dieppe Hospital
  • Elbeuf, France, 76410
    • Elbeuf Hospital
  • Lille, France, 59000
    • UH Lille
  • Montivilliers, France, 76290
    • Le Havre Hospital
  • Rouen, France, 76031
    • UH Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: early switch; early switch of monoclonal antibodies anti-TNF; anti drug antibodies dosage	Biological: anti drug antibodies dosage; anti drug antibodies dosage
Experimental: therapeutic intensification; therapeutic intensification of monoclonal antibodies anti-TNF; anti drug antibodies dosage	Biological: anti drug antibodies dosage; anti drug antibodies dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of ASDAS between inclusion and 24 weeks of treatment	ASDAS will be measured at week 24 and will be compared to day 1	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of patients with ASDAS < 2.1	Frequency of patients with ASDAS < 2.1 at week 24 ASDAS < 2.1 is considered as remission	Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety analysis - Occurence of adverse event	safety analysis in each arm at week 24 Safety analysis include occurence of adverse event in each arm	Week 24

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Olivier VITTECOQ, Prof, UH Rouen

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (Estimate): October 29, 2013

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: spondyloarthritis; monoclonal antibodies anti-TNF; secondary treatment failure
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 2013/006/HP