A Study With CIT-013 in RA Patients
ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCitryll BV
About this trial
The goal of this clinical trial is to learn if CIT-013 works to treat rheumatoid arthritis in adults. It will also learn about the safety of CIT-013. The main questions it aims to answer are:
Does CIT-013 lower the disease activity of RA patients? What medical problems do participants have when receiving CIT-013? Researchers will compare CIT-013 to a placebo (a look-alike substance that contains no drug) to see if CIT-013 works to treat the symptoms of RA.
Participants will:
Take receive CIT-013 or placebo every other week for 6 weeks and 50 mg CIT-013 for 6 weeks Visit the clinic once every 2 weeks for checkups and tests Keep monitor their symptoms during this period
Eligibility criteria
Qualifiers
Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) ≥ 3 months prior to screening
Aged 18-85
DAS28-CRP ≥ 3.2, with ≥ 3 Swollen Joints, and ≥ 3 Tender Joints, and CRP ≥ ULN at screening and confirmed prior to randomization
Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.
Disqualifiers
High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
Contra-indication for CIT-013
Current inflammatory joint disease other than RA (Sjogren with active disease is included).
≥ 1 week for etanercept;
Trial design
Treatments tested in this trial
- CIT-013 low dose
- CIT-013 high dose
- Placebo
- CIT-013 medium dose
Treatment groups
88 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov