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

NCT01971918 | Terminated Phase 4

• 1 other identifier: 2013/006/HP
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 7

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.

Conditions

Spondyloarthritis

Keywords

spondyloarthritis; monoclonal antibodies anti-TNF; secondary treatment failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Frequency of patients with ASDAS < 2.1

  Week 24

Other Outcomes (1)

• Safety analysis - Occurence of adverse event

  Week 24

Study Arms (2)

early switch

EXPERIMENTAL

* early switch of monoclonal antibodies anti-TNF * anti drug antibodies dosage

Biological: anti drug antibodies dosage

therapeutic intensification

EXPERIMENTAL

* therapeutic intensification of monoclonal antibodies anti-TNF * anti drug antibodies dosage

Biological: anti drug antibodies dosage

Interventions

anti drug antibodies dosage BIOLOGICAL

anti drug antibodies dosage

early switch; therapeutic intensification

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (7)

UH Amiens

Amiens, 60, France

Location

UH Caen

Caen, 14000, France

Location

Dieppe Hospital

Dieppe, 76202, France

Location

Elbeuf Hospital

Elbeuf, 76410, France

Location

UH Lille

Lille, 59000, France

Location

Le Havre Hospital

Montivilliers, 76290, France

Location

UH Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Olivier VITTECOQ, Prof

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 29, 2013
• Study Start: May 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

FR (7)