Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06567470

A Study With CIT-013 in RA Patients

Led by Citryll BV · Updated on 2026-03-25

88

Participants Needed

24

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Study With CIT-013 in RA Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients diagnosed with rheumatoid arthritis according to 2010 ACR and EULAR criteria for at least 3 months
  • Age between 18 and 85 years
  • Disease Activity Score (DAS28-CRP) of 3.2 or higher with at least 3 swollen joints and 3 tender joints, and elevated CRP at screening and before randomization
  • Stable treatment with a conventional synthetic disease modifying antirheumatic drug for at least 4 weeks, with use for at least 3 months prior to screening
Not Eligible

You will not qualify if you...

  • Need for immediate start of biological or targeted synthetic DMARD due to high disease activity or severity
  • Contraindication to CIT-013
  • Presence of current inflammatory joint disease other than rheumatoid arthritis (excluding Sjogren's with active disease)
  • Insufficient washout period from previous biological or targeted synthetic DMARDs, varying from 1 week to 6 months depending on the drug
  • Treatment with three or more biological or targeted synthetic DMARDs
  • Use of injectable corticosteroids or oral prednisolone over 10 mg/day within 4 weeks before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 24 locations

1

BE-02

Antwerp, Belgium

Not Yet Recruiting

2

Site BE-01

Leuven, Belgium

Actively Recruiting

3

DE-04

Bamberg, Germany

Actively Recruiting

4

DE-05

Berlin, Germany

Actively Recruiting

5

DE-01

München, Germany

Not Yet Recruiting

6

DE-02

München, Germany

Actively Recruiting

7

DE-03

Ratingen, Germany

Actively Recruiting

8

NL-02

Amsterdam, Netherlands

Actively Recruiting

9

NL-05

Leeuwarden, Netherlands

Actively Recruiting

10

NL-04

Leiden, Netherlands

Withdrawn

11

NL-03

Nijmegen, Netherlands

Not Yet Recruiting

12

NL-01

Rotterdam, Netherlands

Actively Recruiting

13

PL-01

Bialystok, Poland

Actively Recruiting

14

PL-07

Krakow, Poland

Actively Recruiting

15

PL-03

Lublin, Poland

Actively Recruiting

16

PL-02

Poznan, Poland

Actively Recruiting

17

PL-05

Torun, Poland

Actively Recruiting

18

PL-04

Warsaw, Poland

Actively Recruiting

19

ES-02

A Coruña, Spain

Actively Recruiting

20

ES-04

Barcelona, Spain

Actively Recruiting

21

ES-05

Barcelona, Spain

Not Yet Recruiting

22

ES-06

Madrid, Spain

Actively Recruiting

23

ES-01

Santander, Spain

Not Yet Recruiting

24

ES-03

Santiago de Compostela, Spain

Actively Recruiting

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Research Team

L

Leonie Middelink

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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A Study With CIT-013 in RA Patients | DecenTrialz