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 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
PTC Therapeutics · Industry
Who this trial is looking for
This trial is looking for people with active rheumatoid arthritis. Participants will receive either PTC844 or a placebo to assess safety and effects on the disease.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with rheumatoid arthritis.
My rheumatoid arthritis is moderately active or more.
I have not received disease-modifying treatments for rheumatoid arthritis or I did not respond well to them.
My other treatments have been stable for 30 days before joining.
My CRP level is 5 mg/L or higher.
You may not be able to join if
I have a significant health issue that could affect my safety in the trial.
I have Class IV rheumatoid arthritis.
I have a history of blood disorders.
I have had any inflammatory joint disease other than rheumatoid arthritis.
I was diagnosed with rheumatoid arthritis before the age of 17.
I have had cancer in the last 5 years, except for certain skin cancers.
I am allergic to PTC844 or its ingredients.
I have taken certain rheumatoid arthritis treatments 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to placebo in participants with active rheumatoid arthritis (RA).
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* Historical diagnosis of RA as per the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) diagnostic criteria.
* Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-CRP (score of ≥3.2) at sc…
Key Inclusion Criteria:
* Historical diagnosis of RA as per the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) diagnostic criteria.
* Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-CRP (score of ≥3.2) at screening.
* Naïve to disease-modifying treatments for RA or have had an inadequate response to background treatment for RA and/or inability to tolerate disease-modifying antirheumatic drugs, as per investigator's discretion.
* Disease-modifying antirheumatic drugs should be stable and unchanged from 30 days prior to the start of the Screening Period and intend to remain stable and unchanged throughout the course of the study.
* CRP of ≥5 milligrams (mg)/liter (L) at screening.
Key Exclusion Criteria:
* Presence of any clinically significant abnormality at screening, or prior or ongoing medical condition (for example, concomitant illness, psychiatric condition), surgical procedure, medical history, or physical findings that, in the investigator's opinion, could adversely affect the safety of the participant or could impair the assessment of study results.
* Participants with Class IV RA.
* Past medical history of blood dyscrasia, bone marrow abnormality and/or suppression, drug induced thrombocytopenia or idiopathic thrombocytopenia, or bleeding diathesis.
* Past medical history of inflammatory joint disease other than RA or fibromyalgia.
* Rheumatoid arthritis onset at \<17 years of age.
* Past medical history of malignancy within 5 years prior to screening, except for nonmelanoma skin cancers cursed via local resection.
* Participant has a known hypersensitivity to any of the ingredients of PTC844 or to any excipients of the study drug.
* Use or intended use of any prescribed disease-modifying treatments for RA within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit, except for methotrexate, low dose prednisone (\<10 mg/day), hydroxychloroquine, or sulfasalazine, which are permitted as established background single-therapy medications.
* Use or intended use of a combination of methotrexate, low dose prednisone (\<10 mg/day), hydroxychloroquine, or sulfasalazine within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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