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

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Adalimumab; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT01895764

2012-004939-23 (EudraCT Number)

2012-R41 (Other Identifier)

PHRI12-ED-COMARIS

A130042-32 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Adalimumab

Active Comparator group

Description:

adalimumab 40mg every 2 weeks

Treatment:

Drug: Adalimumab

Adalimumab + Methotrexate

Experimental group

Description:

adalimumab 40mg every 2 weeks and methotrexate 10mg per week

Treatment:

Drug: Methotrexate

Drug: Adalimumab