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Can group learning make biotherapy safer for arthritis patients?

NCT ID NCT03838939

Knowledge-focused Sponsor: University Hospital, Clermont-Ferrand 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial investigates whether combining group and individual educational sessions helps patients with chronic inflammatory rheumatism (like rheumatoid arthritis or spondyloarthritis) learn safety skills better than individual sessions alone. Participants are starting their first subcutaneous biotherapy and will be randomly assigned to either individual education or individual plus group sessions. The study measures safety knowledge using a questionnaire at the start and after six months, focusing on recognizing warning signs and managing daily situations like infections or surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Therapeutic education sessions (individual and group)
What this could lead to
If group sessions boost safety skills, this could lead to better self-management and fewer complications for people on biotherapy.
What could go wrong
The trial is relatively small and measures knowledge rather than real-world outcomes, so benefits may not translate into fewer infections or complications.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2021

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 to 80 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: * Patient age \> 18 years old with RA (ACR/EULAR criteria) or SA (ASAS criteria) initiating a first subcutaneous biotherapy. * Patient able to complete a questionnaire * Patient giving informed consent. * Patient covered by social security Exclusion Criteria: * \- Patient with disorder of higher mental function or psychiatric disorders. * Patient previously treated by intravenous biotherapy. * Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis Spondylarthritis spondyloarthropathy

As listed by the trial registrant

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

Rheumatoid arthritis Spondyloarthritis

Contacts and locations

Locations

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003, France

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