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

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ClinicalTrials.gov Identifier: NCT01971918
Recruitment Status : Terminated (lack of recruitment)
First Posted : October 29, 2013
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Spondyloarthritis Biological: anti drug antibodies dosage Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2014
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Variation of ASDAS between inclusion and 24 weeks of treatment [ Time Frame: Week 24 ]
    ASDAS will be measured at week 24 and will be compared to day 1


Secondary Outcome Measures :
  1. Frequency of patients with ASDAS < 2.1 [ Time Frame: Week 24 ]
    Frequency of patients with ASDAS < 2.1 at week 24 ASDAS < 2.1 is considered as remission


Other Outcome Measures:
  1. Safety analysis - Occurence of adverse event [ Time Frame: Week 24 ]
    safety analysis in each arm at week 24 Safety analysis include occurence of adverse event in each arm



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971918


Locations
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France
UH Amiens
Amiens, France, 60
UH Caen
Caen, France, 14000
Dieppe Hospital
Dieppe, France, 76202
Elbeuf Hospital
Elbeuf, France, 76410
UH Lille
Lille, France, 59000
Le Havre Hospital
Montivilliers, France, 76290
UH Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Olivier VITTECOQ, Prof UH Rouen
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01971918    
Other Study ID Numbers: 2013/006/HP
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Keywords provided by University Hospital, Rouen:
spondyloarthritis
monoclonal antibodies anti-TNF
secondary treatment failure
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs