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

Sponsor
University Hospital, Grenoble
Study ID
NCT03561649
Status
Completed

Conditions

  • Spondylitis, Ankylosing

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 14, 2018
Status verified
May 2026
Primary completion
Dec 14, 2019
Completion
May 7, 2020

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Adalimumab
    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.

Primary Outcome Measure

Measurement of disease activity: AS-DAS (Ankylosing Spondylitis - Disease Activity Score) [ Time Frame: 6 months after baseline ]

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