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

Spondyloarthritis Clinical Trial

— STRADA  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01971918
• Other study ID #: 2013/006/HP
• Status: Terminated
• Phase: Phase 4
• First received: October 11, 2013
• Last updated: June 13, 2017
• Start date: May 2014
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spondylarthritis
• Spondyloarthritis

Intervention

Biological:
• anti drug antibodies dosage
anti drug antibodies dosage

Locations

Country	Name	City	State
France	UH Amiens	Amiens
France	UH Caen	Caen
France	Dieppe Hospital	Dieppe
France	Elbeuf Hospital	Elbeuf
France	UH Lille	Lille
France	Le Havre Hospital	Montivilliers
France	UH Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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