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

Ankylosing Spondylitis Clinical Trial

— COMARIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895764
• Other study ID #: PHRI12-ED-COMARIS
• Secondary ID: 2012-004939-23A1
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2013
• Last updated: September 28, 2015
• Start date: March 2013
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
• Methotrexate
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26

Locations

Country	Name	City	State
France	Rhumatologie, CH de BLOIS	Blois
France	Rhumatologie, CHRU de BREST	Brest
France	Rhumatologie, CHD LA ROCHE SUR YON	La Roche Sur Yon
France	Rhumatologie, CHR du MANS	Le Mans
France	Rhumatologie, CHRU de NANTES	Nantes
France	Rhumatologie / IPROS, CHR d'ORLEANS	Orleans
France	Rhumatologie, CHRU de POITIERS	Poitiers
France	Rhumatologie, CHRU de RENNES	Rennes
France	Rhumatologie, CH de SAINT BRIEUC	Saint Brieuc
France	Médecine polyvalente, CH de SAINT NAZAIRE	Saint Nazaire
France	Rhumatologie, CHRU de TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence or absence of antibodies against adalimumab		6 months	No
Secondary	Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)		6 months	No
Secondary	Change from baseline of T and B cells concentrations.		6 months	Yes
Secondary	Change from baseline of "APRIL" and "TNF alpha" concentrations		6 months	No