Tests PTC844 against placebo in adults with active rheumatoid arthritis
Tests PTC844 against a placebo in adults with active rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Study of PTC844 in Participants With Active Rheumatoid Arthritis
Key facts
- Where
- Tbilisi, GeorgiaSee the 7 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07779616, who can take part
Where in Georgia
- Aversi Clinic LLCTbilisi, GeorgiaNot yet recruiting
- JSC "Jerarsi"Tbilisi, GeorgiaNot yet recruiting
- JSC Vian - Iv. Bokeria University HospitalTbilisi, GeorgiaNot yet recruiting
- JSC VIAN Caraps MedlineTbilisi, GeorgiaNot yet recruiting
- LTD Caucasus Medical CentreTbilisi, GeorgiaNot yet recruiting
- Ltd InnovaTbilisi, GeorgiaNot yet recruiting
- The First Medical Center LLCTbilisi, GeorgiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PTC Therapeutics
- Trial code
- NCT07779616
- Record updated
- 6 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 2A, Proof-of-Concept, Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PTC844 in Participants With Active Rheumatoid Arthritis
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).
Inclusion: 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.
Exclusion: 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; 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; 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; Rheumatoid arthritis onset at <17 years of age; Participants with Class IV RA; 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.