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

Phase 4

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Adalimumab; Drug: Methotrexate

• Registration Number: NCT01895764
• Lead Sponsor: University Hospital, Tours

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adalimumab + Methotrexate	Methotrexate	adalimumab 40mg every 2 weeks and methotrexate 10mg per week
Adalimumab	Adalimumab	adalimumab 40mg every 2 weeks
Adalimumab + Methotrexate	Adalimumab	adalimumab 40mg every 2 weeks and methotrexate 10mg per week

Primary Outcome Measures

Name	Time	Method
presence or absence of antibodies against adalimumab	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)	6 months
Change from baseline of T and B cells concentrations.	6 months
Change from baseline of "APRIL" and "TNF alpha" concentrations	6 months

Trial Locations

Locations (11)

Médecine polyvalente, CH de SAINT NAZAIRE; 🇫🇷 Saint Nazaire, France

Rhumatologie, CHRU de RENNES; 🇫🇷 Rennes, France

Rhumatologie, CHD LA ROCHE SUR YON; 🇫🇷 La Roche Sur Yon, France

Rhumatologie / IPROS, CHR d'ORLEANS; 🇫🇷 Orleans, France

Rhumatologie, CHR du MANS; 🇫🇷 Le Mans, France

Rhumatologie, CHRU de NANTES; 🇫🇷 Nantes, France

Rhumatologie, CH de SAINT BRIEUC; 🇫🇷 Saint Brieuc, France

Rhumatologie, CH de BLOIS; 🇫🇷 Blois, France

Rhumatologie, CHRU de BREST; 🇫🇷 Brest, France

Rhumatologie, CHRU de POITIERS; 🇫🇷 Poitiers, France

Rhumatologie, CHRU de TOURS; 🇫🇷 Tours, France