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Could a cancer drug ease arthritis in scleroderma patients?

NCT ID NCT01748084

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether rituximab, a drug used for certain cancers and autoimmune diseases, can reduce joint pain and swelling in people with systemic sclerosis (scleroderma). Twenty-two adults with active arthritis took rituximab or a placebo, plus standard care. Researchers counted tender and swollen joints to see if the drug helped.

What this could mean

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

Active substance
rituximab
What this could lead to
If it works, this could point toward a treatment for arthritis in people with systemic sclerosis, improving joint pain and quality of life.
What could go wrong
This is a small, early-phase trial with only 22 participants, so results may not apply to everyone. Rituximab can cause infusion reactions and increase infection risk.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

22 people

The number who actually took part.

Started

Apr 2013

Finished

Apr 2016

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: * Systemic sclerosis fulfilling ACR or LeRoy's criteria * Active polyarthritis defined by \> 6/53 tender joints and \> 4/53 swollen joints * Ongoing first line therapy by prednisone (max 10 mg/d) and DMARDS (methotrexate, leflunomide, azathioprine or mycophenolate) * Birth control if applicable Exclusion Criteria: * Overlap syndrome defined by clinical symptoms and positive specific auto-antibodies (anti-CCP, anti-SSA, anti-DNA DNA anti-Sm) (Rheumatoid factors and anti-RNP are not exclusion criteria) * Past therapy with Rituximab. * Severe and uncontrolled disease with renal, liver or haematological (neutropenia \< 1500 / mm3) failures, pulmonary (FVC \< 50%) or cardiac insufficiencies (LVEF \< 50%) * Not stable corticosteroid therapy or cyclophosphamide use in the last 6 months * Infectious risk : viral infections by B or C hepatitis or HIV, hypogammaglobulinemia (\< 6 G/L), opportunistic infection or infection requiring IV antibiotics in the last 3 months. * Neoplastic solid tumor in the last 5 years * Drug or alcool abuses * Receiving patient or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months)

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Conditions

The condition(s) this trial relates to.

arthritic joint disease diffuse scleroderma pulmonary fibrosis systemic sclerosis

As listed by the trial registrant

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

Systemic sclerosis

Contacts and locations

Locations

  • Cochin Hospital

    Paris, 75014, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.