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Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

Information source: University Hospital, Tours
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ankylosing Spondylitis

Intervention: Adalimumab (Drug); Methotrexate (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University Hospital, Tours

Official(s) and/or principal investigator(s):
Emilie DUCOURAU, MD, Principal Investigator, Affiliation: CHRU de TOURS

Summary

The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.

Clinical Details

Official title: Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: presence or absence of antibodies against adalimumab

Secondary outcome:

Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)

Change from baseline of T and B cells concentrations.

Change from baseline of "APRIL" and "TNF alpha" concentrations

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject 18 years of age or older

- Able and willing to give written informed consent and to comply with the requirements

of the study protocol

- Subject met the definition of Ankylosing Spondylitis (AS) based on ASAS Criteria

- Subject with active AS, has had an inadequate response, an intolerance or an to one

or more nonsteroidal anti-inflammatory drugs Exclusion Criteria:

- Previous adalimumab treatment or previous treatment with more than one anti TNF alpha

therapy.

- Previous methotrexate treatment, not stopped 3 month before inclusion

- Surgery scheduled during study

- Female subject without method of contraception

- Contraindication to adalimumab or methotrexate

Locations and Contacts

Rhumatologie, CH de BLOIS, Blois 41000, France

Rhumatologie, CHRU de BREST, Brest 29609, France

Rhumatologie, CHD LA ROCHE SUR YON, La Roche Sur Yon 85925, France

Rhumatologie, CHR du MANS, Le Mans 72037, France

Rhumatologie, CHRU de NANTES, Nantes 44093, France

Rhumatologie / IPROS, CHR d'ORLEANS, Orleans 45032, France

Rhumatologie, CHRU de POITIERS, Poitiers 86021, France

Rhumatologie, CHRU de RENNES, Rennes 35203, France

Rhumatologie, CH de SAINT BRIEUC, Saint Brieuc 22027, France

M├ędecine polyvalente, CH de SAINT NAZAIRE, Saint Nazaire 44606, France

Rhumatologie, CHRU de TOURS, Tours 37044, France

Additional Information

Starting date: March 2013
Last updated: April 8, 2015

Page last updated: August 23, 2015

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