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Can a second drug stop the body from rejecting arthritis treatment?

NCT ID NCT01895764

Disease control Sponsor: University Hospital, Tours Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding methotrexate to adalimumab (a biologic drug) reduces the chance that the body makes antibodies against adalimumab in people with ankylosing spondylitis. About 110 adults with active disease who did not respond well to NSAIDs took part. The goal was to see if the combination helps the biologic stay effective longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

110 people

The number who actually took part.

Started

Mar 2013

Finished

Apr 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankylosing spondylitis

Contacts and locations

Locations

  • Médecine polyvalente, CH de SAINT NAZAIRE

    Saint-Nazaire, 44606, France

  • Rhumatologie / IPROS, CHR d'ORLEANS

    Orléans, 45032, France

  • Rhumatologie, CH de BLOIS

    Blois, 41000, France

  • Rhumatologie, CH de SAINT BRIEUC

    Saint-Brieuc, 22027, France

  • Rhumatologie, CHD LA ROCHE SUR YON

    La Roche-sur-Yon, 85925, France

  • Rhumatologie, CHR du MANS

    Le Mans, 72037, France

  • Rhumatologie, CHRU de BREST

    Brest, 29609, France

  • Rhumatologie, CHRU de NANTES

    Nantes, 44093, France

  • Rhumatologie, CHRU de POITIERS

    Poitiers, 86021, France

  • Rhumatologie, CHRU de RENNES

    Rennes, 35203, France

  • Rhumatologie, CHRU de TOURS

    Tours, 37044, France

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