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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Adalimumab
Methotrexate
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rhumatologie, CH de BLOIS
  • Rhumatologie, CHRU de BREST
  • Rhumatologie, CHD LA ROCHE SUR YON
  • Rhumatologie, CHR du MANS
  • Rhumatologie, CHRU de NANTES
  • Rhumatologie / IPROS, CHR d'ORLEANS
  • Rhumatologie, CHRU de POITIERS
  • Rhumatologie, CHRU de RENNES
  • Rhumatologie, CH de SAINT BRIEUC
  • Médecine polyvalente, CH de SAINT NAZAIRE
  • Rhumatologie, CHRU de TOURS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Adalimumab

Adalimumab + Methotrexate

Arm Description

adalimumab 40mg every 2 weeks

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

Outcomes

Primary Outcome Measures

presence or absence of antibodies against adalimumab

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2013
Last Updated
September 28, 2015
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01895764
Brief Title
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Acronym
COMARIS
Official Title
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
ankylosing spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
adalimumab 40mg every 2 weeks
Arm Title
Adalimumab + Methotrexate
Arm Type
Experimental
Arm Description
adalimumab 40mg every 2 weeks and methotrexate 10mg per week
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Metoject
Intervention Description
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
Primary Outcome Measure Information:
Title
presence or absence of antibodies against adalimumab
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time Frame
6 months
Title
Change from baseline of T and B cells concentrations.
Time Frame
6 months
Title
Change from baseline of "APRIL" and "TNF alpha" concentrations
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie DUCOURAU, MD
Organizational Affiliation
CHRU de TOURS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhumatologie, CH de BLOIS
City
Blois
ZIP/Postal Code
41000
Country
France
Facility Name
Rhumatologie, CHRU de BREST
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Rhumatologie, CHD LA ROCHE SUR YON
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Rhumatologie, CHR du MANS
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Rhumatologie, CHRU de NANTES
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Rhumatologie / IPROS, CHR d'ORLEANS
City
Orleans
ZIP/Postal Code
45032
Country
France
Facility Name
Rhumatologie, CHRU de POITIERS
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Rhumatologie, CHRU de RENNES
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
Rhumatologie, CH de SAINT BRIEUC
City
Saint Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
Médecine polyvalente, CH de SAINT NAZAIRE
City
Saint Nazaire
ZIP/Postal Code
44606
Country
France
Facility Name
Rhumatologie, CHRU de TOURS
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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