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New treatment option for Rheumatoid Arthritis
Official title A Study With CIT-013 in RA Patients
ClinicalTrials.gov ID: NCT06567470
What this study is testing
What is CIT-013 low dose?
CIT-013 low dose is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for 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
- 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.
- 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 and older
You may be able to join if
- Male or female patients with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) and the European League...
- 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.
You likely can't join if
- 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).
- 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;
See the full eligibility criteria
- 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.
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Belgium
- Leuven, Belgium
- Bamberg, Germany
- Berlin, Germany
- München, Germany
- Ratingen, Germany
- Amsterdam, Netherlands
- Leeuwarden, Netherlands
- Leiden, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- Bialystok, Poland
- Krakow, Poland
- Lublin, Poland
- Poznan, Poland
- Torun, Poland
- Warsaw, Poland
- A Coruña, Spain
- Barcelona, Spain
- Madrid, Spain
+ 2 more site(s).
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 - 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Belgium; Leuven, Belgium; Bamberg, Germany; Berlin, Germany; München, Germany; Ratingen, Germany and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.