Rheumatoid Arthritis study: PTC844
Official title Study of PTC844 in Participants With Active Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT07779616
What this study is testing
What is PTC844?
PTC844 is an investigational medicine being studied to see if it can help treat rheumatoid arthritis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether PTC844 is safe and how it behaves in the body compared to a pretend treatment.
- Who it's for
- You may be able to join if you have active rheumatoid arthritis and meet the study’s health criteria.
- What's involved
- You will receive either PTC844 or a pretend treatment and have blood tests to see how the drug works.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Historical diagnosis of RA as per the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) diagnostic...
- 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 should be stable and unchanged from 30 days prior to the start of the Screening Period and intend to remain...
- CRP of ≥5 milligrams (mg)/liter (L) at screening. Key
You likely can't join if
- Presence of any clinically significant abnormality at screening, or prior or ongoing medical condition (for example, concomitant illness, psychiatric...
- Participants with Class IV RA.
- Past medical history of blood dyscrasia, bone marrow abnormality and/or suppression, drug induced thrombocytopenia or idiopathic thrombocytopenia, or...
- 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.
See the full eligibility 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Chandler, Arizona, United States
- Westlake Village, California, United States
- Cutler Bay, Florida, United States
- Miami, Florida, United States
- Winter Park, Florida, United States
- Irving, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chandler, Arizona, United States; Westlake Village, California, United States; Cutler Bay, Florida, United States; Miami, Florida, United States; Winter Park, Florida, United States; Irving, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.