Ankylosing SpondylitisPhase 4COMARISNCT01895764
Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
A Phase 4 study testing Adalimumab and Methotrexate in people with Ankylosing Spondylitis, run by University Hospital, Tours at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Adalimumab and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 11 sitesFrance
- Study dates
- 20 Mar 2013to 27 Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Rhumatologie, CH de BLOIS
Blois, 41000
Rhumatologie, CHRU de BREST
Brest, 29609
Rhumatologie, CHD LA ROCHE SUR YON
La Roche-sur-Yon, 85925
Rhumatologie, CHR du MANS
Le Mans, 72037
Rhumatologie, CHRU de NANTES
Nantes, 44093
Rhumatologie / IPROS, CHR d'ORLEANS
Orléans, 45032
Rhumatologie, CHRU de POITIERS
Poitiers, 86021
Rhumatologie, CHRU de RENNES
Rennes, 35203
Rhumatologie, CH de SAINT BRIEUC
Saint-Brieuc, 22027
Médecine polyvalente, CH de SAINT NAZAIRE
Saint-Nazaire, 44606
Rhumatologie, CHRU de TOURS
Tours, 37044
About this study
The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Adalimumab, Methotrexate
- Keywords
- ankylosing spondylitis
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
MethotrexateDrug
Also called Metoject
methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Active comparator | adalimumab 40mg every 2 weeks Receives: Drug: Adalimumab |
| Adalimumab + Methotrexate | Experimental | adalimumab 40mg every 2 weeks and methotrexate 10mg per week Receives: Drug: Adalimumab; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence or absence of antibodies against adalimumab
Measured: 6 months
Secondary outcomes (3)
Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Measured: 6 months
Change from baseline of T and B cells concentrations.
Measured: 6 months
Change from baseline of "APRIL" and "TNF alpha" concentrations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study start20 Mar 2013
- Primary completion27 Apr 2015
- Study completion27 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie DUCOURAU, MD, Principal investigator, CHRU de TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895764
- Sponsor's protocol ID
- PHRI12-ED-COMARIS
- Other IDs
- 2012-004939-23, A130042-32, 2012-R41
- Acronym
- COMARIS
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2013
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ducourau E, Rispens T, Samain M, Dernis E, Le Guilchard F, Andras L, Perdriger A, Lespessailles E, Martin A, Cormier G, Armingeat T, Devauchelle-Pensec V, Gervais E, Le Goff B, de Vries A, Piver E, Paintaud G, Desvignes C, Ternant D, Watier H, Goupille P, Mulleman D. Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial. RMD Open. 2020 Jan;6(1):e001047. doi: 10.1136/rmdopen-2019-001047. Epub 2020 Jan 9.
PubMed 31958280
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)
- ClinicalTrials.gov ID
- NCT01895764
- Acronym / sponsor ID
- COMARIS / PHRI12-ED-COMARIS
- Conditions
- Ankylosing Spondylitis
- Keywords
- ankylosing spondylitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 20 Mar 2013 (actual)
- Primary completion
- 27 Apr 2015 (actual)
- Study completion
- 27 Apr 2015 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Active comparator | Drug: Adalimumabadalimumab 40mg every 2 weeks |
| Adalimumab + Methotrexate | Experimental | Drug: Adalimumab, Drug: Methotrexateadalimumab 40mg every 2 weeks and methotrexate 10mg per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: Humiraadalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26 | Drug | Adalimumab, Adalimumab + Methotrexate |
| MethotrexateAlso: Metojectmethotrexate, subcutaneous injection, 10mg per week, week -2 until week 26 | Drug | Adalimumab + Methotrexate |
Primary outcome
presence or absence of antibodies against adalimumab
Time frame: 6 months
3 secondary outcomes
Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: 6 months
Change from baseline of T and B cells concentrations.
Time frame: 6 months
Change from baseline of "APRIL" and "TNF alpha" concentrations
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Results publication: PubMed 31958280Ducourau E, Rispens T, Samain M, Dernis E, Le Guilchard F, Andras L, Perdriger A, Lespessailles E, Martin A, Cormier G, Armingeat T, Devauchelle-Pensec V, Gervais E, Le Goff B, de Vries A, Piver E, Paintaud G, Desvignes C, Ternant D, Watier H, Goupille P, Mulleman D. Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial. RMD Open. 2020 Jan;6(1):e001047. doi: 10.1136/rmdopen-2019-001047. Epub 2020 Jan 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie DUCOURAU, MD principal investigator
CHRU de TOURS
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab and Methotrexate in people with Ankylosing Spondylitis, run by University Hospital, Tours at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence or absence of antibodies against adalimumab (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01895764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.