Comparative Analysis of Two Therapeutic Strategies in Pat... | NCT01971918

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

NCT01971918

Sponsor

University Hospital, Rouen

Status

Terminated

Last Update Posted

Jun 15, 2017Actual

Enrollment

8Actual

Phase

Phase 4

Conditions

Spondyloarthritis

Interventions

anti drug antibodies dosage

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recruitment

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Oct 11, 2013

First Submission Date that Met QC Criteria

Oct 23, 2013

First Posted Date

Oct 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2017

Last Update Posted Date

Jun 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
anti drug antibodies dosage	Biological	anti drug antibodies dosage	early switch therapeutic intensification

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Olivier VITTECOQ, Prof	UH Rouen	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UH Amiens		Amiens		60	France
UH Caen

Condition Browse Module

MeSH Terms

ID	Term
D025241	Spondylarthritis

Ancestor Terms

ID	Term
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided