Prediction of Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive SpA

NCT03561649 | Completed

• 1 other identifier: 38RC17.378
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

The main objective of this trial is to search for biomarkers associated with the success of adalimumab treatment in order to generate an algorithm to predict the response to this treatment at 6 months in spondyloarthritis and to define its metrological properties on this cohort. The algorithm will allow to better target patients who will have an important benefit/risk ratio for adalimumab treatment.

Conditions

Spondylitis, Ankylosing

Keywords

TNF inhibitor; Adalimumab; Spondyloarthritis; Biomarkers analysis; Personalized medicine

Outcome Measures

Primary Outcomes (1)

• Measurement of disease activity: AS-DAS (Ankylosing Spondylitis - Disease Activity Score)

  The primary endpoint is the clinically important ASAS response corresponding to a variation in ASDAS CRP ≥ 1.1.

  6 months after baseline

Secondary Outcomes (2)

• Measurement of BASDAI response (Bath Ankylosing Spondylitis Disease Activity Index)

  6 months after baseline

• Biomarkers analysis for personalized medicine

  At baseline and 6 months later

Study Arms (1)

Adalimumab

EXPERIMENTAL

Adalimumab is not the experimental study drug. This treatment justifies the inclusion of patients and is used in accordance with its marketing authorization. The patients will be seen as part of their follow-up consultation in Rheumatology. Modality of administration: The baseline visit should take place no more than 4 weeks before the start of adalimumab treatment, 40mg every 2 weeks, subcutaneously, in accordance with Summary of Product Characteristics. At baseline and 6 months follow-up visits, a single blood draw for the biomarker dosage will be added to the standard patient health care follow-up. The clinical examination will also be performed at these two visits, and the clinical response will be assessed after 6 months of adalimumab treatment at M6 follow-up visit.

Drug: Adalimumab

Interventions

Adalimumab DRUG

This trial will be conducted by rheumatologists who can follow patients with SpA and conduct this trial in good conditions and in accordance with regulatory and legal recommendations.

Adalimumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with spondyloarthritis validating ASAS or modified New York criteria for which adalimumab treatment is indicated, and performing the pre-biotherapy assessment;
• Between 18 and 70 years old;
• Biotherapy naive;
• Who can be regularly monitored for 6 months;
• Able to take all the treatment;
• Effective contraception for patients of childbearing age (oral contraceptive, intrauterine device, implant, spermicide, surgical sterilization or abstinence) during the study and at least for 5 months after the last injection;
• Able to read and understand the terms of the protocol;
• Having dated and signed the informed consent form of the trial;
• Affiliated to a social security scheme.

You may not qualify if:

• Patients having a contraindication to an anti-TNF;
• Surgical operation scheduled during the trial;
• Having difficulty understanding the French language;
• Having impaired upper functions (dementia of Alzheimer type, etc...);
• Psycho-social instability incompatible with regular follow-up (homeless, addictive behavior, history of psychiatric pathology or any other comorbidity which would make a free and informed consent impossible or limit adherence to the protocol);
• Described in articles L.1121-5 to L.1121-8 of the Personal Status Code: pregnant, parturient and nursing women; persons in detention by judicial or administrative decision; adults subject to a legal protection order;
• Already participating in interventional research.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• SINNOVIAL: collaborator

Study Sites (5)

CH de Belfort

Belfort, 90016, France

Location

CHU de Besançon

Besançon, 25030, France

Location

CHRU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Grenoble

Échirolles, 38434, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (25)

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MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Athan BAILLET, MD, PHD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: June 19, 2018
• Study Start: June 14, 2018
• Primary Completion: December 14, 2019
• Study Completion: May 7, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)