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Can a higher dose of infliximab tame stubborn rheumatoid arthritis?

NCT ID NCT00691028

Disease control Sponsor: Tanabe Pharma Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether increasing the dose of infliximab (a drug that blocks inflammation) helps people with active rheumatoid arthritis who did not improve enough with methotrexate alone. 327 adults received one of three doses (3, 6, or 10 mg/kg) by IV infusion over nearly a year. Researchers measured joint pain, swelling, and physical function to see if higher doses worked better.

What this could mean

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

Active substance
Infliximab (also known as TA-650, Remicade) given by intravenous infusion, plus methotrexate
What this could lead to
If successful, this study could show that a higher dose of infliximab helps control rheumatoid arthritis symptoms better in people who did not get enough relief from methotrexate alone.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. Infliximab can increase the risk of serious infections and allergic reactions. Higher doses may also raise the chance of side effects without adding benefit.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

327 people

The number who actually took part.

Start date

Sep 2005

Finished

May 2007

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

20 to 75 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 with active RA in spite of stable dose of MTX Exclusion Criteria: * Having received infliximab in the past * Having a history of serious infection which caused hospitalization within 6 months before the registration * Having an active tuberculosis * Having a complication or a history of malignancy within 5 years before the registration

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

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

Rheumatoid arthritis

More trials for these conditions

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