NCT06567470CompletedPhase 2
A Study With CIT-013 in RA Patients
A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 16 Aug 2024
- Start date
- 29 Jul 2025
- Primary completion date
- 2 Jul 2026
- Lead sponsor
- Citryll BV
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06567470
- EU CT number
- 2024-517356-35-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 96
- From 29 Jul 2025 to the primary completion date, 2 Jul 2026
- 25 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The washout period for bDMARD or JAKi prior to the first dose of investigational product should be at least:
- ≥ 1 week for etanercept;
- ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab;
- ≥ 6 months year for rituximab;
- ≥ 2 weeks for tsDMARD (either investigational or commercially available treatment).
- Treated with ≥ 3 bDMARD or tsDMARD
- Injectable corticosteroids or treatment with \> 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
Other illness
- High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
- Current inflammatory joint disease other than RA (Sjogren with active disease is included).
Other
- Contra-indication for CIT-013
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Sozialstiftung Bamberg Coordinator of this site? Confirm its status | Bamberg | Germany | Completed |
| Rheumatologische Schwerpunktpraxis Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Studienambulanz Rheumazentrum Ratingen GbR Coordinator of this site? Confirm its status | Ratingen | Germany | Completed |
| University Of A Coruna Coordinator of this site? Confirm its status | A Coruna | Spain | Completed |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Instituto De Investigacion Marques De Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Universidade De Santiago De Compostela Coordinator of this site? Confirm its status | Santiago De Compostela | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
| Frisius MC Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Completed |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Completed |
| Prof. Herbert Kellner Coordinator of this site? Confirm its status | Munich | Netherlands | Completed |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| Maasstad Ziekenhuis Stichting Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Clinicmed Daniluk Nowak Sp. k. Coordinator of this site? Confirm its status | Bialystok | Poland | Active, not recruiting |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Reumed Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Medyczne Centrum Hetmańska Piotr Leszczyński Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Torun | Poland | Active, not recruiting |
| Wsd Medi Clinical Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.