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

September 28, 2015 updated by: University Hospital, Tours
The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Blois, France, 41000
        • Rhumatologie, CH de BLOIS
      • Brest, France, 29609
        • Rhumatologie, CHRU de BREST
      • La Roche Sur Yon, France, 85925
        • Rhumatologie, CHD LA ROCHE SUR YON
      • Le Mans, France, 72037
        • Rhumatologie, CHR du MANS
      • Nantes, France, 44093
        • Rhumatologie, CHRU de NANTES
      • Orleans, France, 45032
        • Rhumatologie / IPROS, CHR d'ORLEANS
      • Poitiers, France, 86021
        • Rhumatologie, CHRU de POITIERS
      • Rennes, France, 35203
        • Rhumatologie, CHRU de RENNES
      • Saint Brieuc, France, 22027
        • Rhumatologie, CH de SAINT BRIEUC
      • Saint Nazaire, France, 44606
        • Médecine polyvalente, CH de SAINT NAZAIRE
      • Tours, France, 37044
        • Rhumatologie, CHRU de TOURS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adalimumab
adalimumab 40mg every 2 weeks
Drug: Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Other Names:
  • Humira
Experimental: Adalimumab + Methotrexate
adalimumab 40mg every 2 weeks and methotrexate 10mg per week
Drug: Adalimumab
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Other Names:
  • Humira
Drug: Methotrexate
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
Other Names:
  • Metoject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence or absence of antibodies against adalimumab
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Emilie DUCOURAU, MD, CHRU de Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

July 5, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRI12-ED-COMARIS
  • 2012-004939-23 (EudraCT Number)
  • A130042-32 (Other Identifier: ANSM)
  • 2012-R41 (Other Identifier: CPP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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