Oral AP1189 for Early Rheumatoid Arthritis

A Dose Response Study to Evaluate the Efficacy and Safety of Oral AP1189 Administered in Disease-Modifying Anti-Rheumatic Drug (DMARD) naïve Participants Participants With Early Rheumatoid Arthritis

Recruiting Phase 2 Interventional Study
Rheumatoid Arthritis (RA)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
SynAct Pharma Aps · Industry
Who this trial is looking for

This trial is looking for people with early rheumatoid arthritis who have not taken certain arthritis medications before. Participants will take the study drug AP1189 for 12 weeks along with methotrexate and attend regular visits to monitor their health.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with rheumatoid arthritis.
  • I have had rheumatoid arthritis for no longer than 6 months.
  • I have at least 6 tender and 6 swollen joints.
  • I have high disease activity as shown by my test results.
  • I am willing to comply with the study visits and treatment plan.
  • I am a female of childbearing potential with a negative pregnancy test.
  • I practice two methods of birth control with my partner.

You may not be able to join if

  • I have another autoimmune disease besides rheumatoid arthritis.
  • I have any current inflammatory joint disease other than rheumatoid arthritis.
  • I have severe health issues that could interfere with the trial.
  • I have a history of active cancer in the past year.
  • I have serious liver or kidney problems.
  • I have low blood counts or other significant lab test issues.
  • I have used any systemic corticosteroids recently.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Signed and dated informed consent obtained before undergoing any trial-specific procedure. * Participants with definite RA diagnosis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. * Disease durat…
Contacts

Thomas Jonassen, MD

+45 4015 6669

tj@synactpharma.com

CONTACT