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New combo therapy for rheumatoid arthritis shows promise in early trial

NCT ID NCT01143337

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 adding an experimental drug called MP-435 to standard methotrexate treatment helps people with rheumatoid arthritis who don't get enough relief from methotrexate alone. 112 adults took either MP-435 or a placebo (dummy pill) plus their usual methotrexate for 12 weeks. The main goal was to see if more people in the MP-435 group had at least a 20% improvement in joint pain, swelling, and daily function. The trial is now complete.

What this could mean

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

Active substance
MP-435 (an experimental drug) plus methotrexate
What this could lead to
If it works, this could point toward a new treatment option for rheumatoid arthritis when methotrexate alone isn't enough.
What could go wrong
This is an early Phase 2 exploratory study with only 112 people. It may not show enough benefit or could have side effects. Success in this trial does not guarantee a future approved 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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

112 people

The number who actually took part.

Start date

Jun 2010

Finished

Mar 2012

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: * Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987) for at least 6 months. * Subjects who inadequately response for stable dose of MTX. Exclusion Criteria: * Patients with Class IV functional activity by the Steinbrocker's scale. * Patients who have received a biological agent in the past. * Patients who have other rheumatic diseases, or who have other diseases with joint symptoms. * Patients with severe or uncontrolled endocrine, psychiatric, cardiac, hematological, pulmonary, hepatic, kidney, gastrointestinal, or thyroid disease.

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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

Contacts and locations

Locations

  • Investigational site

    Osaka, Japan

More trials for these conditions

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