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Proof of Concept trial with CIT-013 in Rheumatoid Arthritis
EU CTIS ID: 2024-517356-35-00
What this study is testing
The primary objective of this trial is to evaluate the efficacy of CIT-013 in patients with moderately active RA.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 Against Rheumatism (EULAR) ≥ 3 months prior to screening (diagnosis based on medical records).
- ≥ 18 years of age.
- Disease Activity Score ≥ 3.2 AND ≥ 3 Swollen Joints AND ≥ 3 Tender Joints, AND CRP/ESR ≥ upper limit of normal (ULN).
- Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.
- Agree to use adequate contraception during the trial for women of childbearing potential (WOCBP), and for 31 weeks after the last dose of IP, and must have a negative pregnancy test prior to entry into the trial. Whether female participants are of childbearing potential needs to be evaluated according to the criteria in Annex 4. Contraceptive Guidance.
- Female participants must agree to refrain from donating ova during the trial and for at least 31 weeks after the last dose of IP.
You likely can't join if
- Current inflammatory joint disease other than RA.
- Use of bDMARD or tsDMARD prior to the first dose of IP, unless the washout period for bDMARDs or tsDMARD prior to the first dose of IP is at least: e) ≥ 2 weeks for etanercept; f) ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; g) ≥ 6 months for rituximab; h) ≥ 1 week of a targeted synthetic DMARD (tsDMARD).
- Prior use of >3 biological DMARD (bDMARD) or tsDMARD treatments.
- Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
- History of malignancy with exception of non-melanoma skin cancer that has been excised and cured.
- Active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus infection, as tested and confirmed during screening
See the full eligibility criteria
Who can join
- 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 (diagnosis based on medical records).
- ≥ 18 years of age.
- Disease Activity Score ≥ 3.2 AND ≥ 3 Swollen Joints AND ≥ 3 Tender Joints, AND CRP/ESR ≥ upper limit of normal (ULN).
- Stable on a conventional synthetic disease modifying antirheumatic drug for ≥ 4 weeks (csDMARD). This drug must have been used for ≥ 3 months.
- Agree to use adequate contraception during the trial for women of childbearing potential (WOCBP), and for 31 weeks after the last dose of IP, and must have a negative pregnancy test prior to entry into the trial. Whether female participants are of childbearing potential needs to be evaluated according to the criteria in Annex 4. Contraceptive Guidance.
- Female participants must agree to refrain from donating ova during the trial and for at least 31 weeks after the last dose of IP.
- Agree to use adequate contraception and refrain from donating sperm during the trial, and for 18 weeks after the last dose of IP, for male participants.
- Body mass index is between 18 and 35 kg/m2, inclusive.
- Willing and able to give written informed consent.
What rules you out
- Current inflammatory joint disease other than RA.
- Use of bDMARD or tsDMARD prior to the first dose of IP, unless the washout period for bDMARDs or tsDMARD prior to the first dose of IP is at least: e) ≥ 2 weeks for etanercept; f) ≥ 4 weeks for adalimumab, infliximab, certolizumab, golimumab, abatacept, tocilizumab, and sarilumab; g) ≥ 6 months for rituximab; h) ≥ 1 week of a targeted synthetic DMARD (tsDMARD).
- Prior use of >3 biological DMARD (bDMARD) or tsDMARD treatments.
- Injectable corticosteroids or treatment with > 10 mg/day dose of oral prednisolone or equivalent within 4 weeks prior to screening.
- History of malignancy with exception of non-melanoma skin cancer that has been excised and cured.
- Active hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus infection, as tested and confirmed during screening
- Pregnant or lactating or planning to get pregnant during the duration of the trial.
- Evidence of active tuberculosis (TB) or being at high risk for TB, assessed according to local site procedures.
- History of more than one episode of herpes zoster in the 12 months prior to screening or any opportunistic infection in the 12 months prior to screening, excluding localized mucocutaneous candidiasis, as reported by participants.
- High clinical activity or disease severity requiring the immediate start of a biological DMARD (bDMARD) or targeted synthetic DMARD (tsDMARD).
- Receipt of live vaccine or live therapeutic infectious agent within the 4 weeks prior to screening or expected to be in need of this during the active part of the trial.
- History of severe allergies, non-allergic drug reactions, or multiple drug allergies.
- Known hypersensitivity to any of the inactive ingredients of the trial treatment.
- Any other multi-system autoimmune disease.
- Significant clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, at discretion of the Investigator (or designee).
- Any other condition which, in the Investigator’s opinion will interfere with completion of the trial.
- Participant has taken an investigational drug within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this trial.
- Being an employee of the Investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee or the Investigator.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.