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708 patients tracked to uncover clues about spinal disease

NCT ID NCT01648907

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed 708 adults with early inflammatory back pain for up to 5 years. Researchers collected data to better understand how the disease progresses, what predicts joint damage, and how to improve diagnosis. The goal was to gather knowledge, not to test a new treatment.

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.

Participants

708 people

The number who actually took part.

Started

Oct 2007

Finished

Feb 2022

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.

Who is studied

Patients presenting early inflammatory back pain of more than 3 months and less than 3 years

Ages

18 to 50 years

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: * Patients aged over 18 and under 50 years * Inflammatory back pain (buttock, lumbar or thoracic spine) fulfilling either the Calin orBerlin criteria : * Calin criteria (at least 4 of 5 criteria must be met) (ref. 25): * Insidious onset * Onset before age 40 * Persistence since at least three months * Morning stiffness 30 minutes * Improvement with exercise * Berlin criteria (at least 2 of 4 criteria must be met) (ref. 26): * Morning stiffness 30 minutes * Improvement with exercise and absence of improvement at rest * Nocturnal pain in the second part of the night * Alternating buttock pain * Symptom duration more than 3 months and less than 3 years * Symptoms suggestive of spondyloarthritis according to the local investigator's assessment(e.g. score ≥5 on a 0 to 10 numerical rating scale in which 0 = no suggestive and 10 = verysuggestive of spondyloarthritis) * Realization of a prior medical examination (article L.1121-11 of the Code of the Public health) * Informed consent Dated and signed voluntarily Exclusion Criteria: * Other spinal disease clearly defined (eg symptomatic mechanical discopathy) * Pregnant woman * History of alcoholism, drug addiction, psychological problems, severe co-morbidities which might interfere with the validity of the informed consent and/or prevent an optimal compliance of the patient to the cohort * It was possible to include patients who have received or are receiving a thorough treatment such as Sulfasalazine, Methotrexate or Azathioprine. However any history of treatment with biotherapy including anti-TNF therapy defined exclusion criteria * Corticosteroid intake was permitted only in case of a dose lower than 10 mg prednisoneper day and stable for at least 4 weeks prior baseline * MRI contraindication * No affiliation to the French National Social Security System

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Conditions

The condition(s) this trial relates to.

Back Pain Spondylarthritis spondyloarthropathy

As listed by the trial registrant

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

Contacts and locations

Locations

  • Department of Rheumatology, Cochin Hospital

    Paris, 75014, France