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Study of CIT-013 at Three Different Doses for Patients with Moderately Active Rheumatoid Arthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is investigating the effects of a medication called CIT-013 on rheumatoid arthritis. Rheumatoid arthritis is a chronic inflammatory condition that affects the joints, causing pain, swelling, and stiffness. The purpose of this study is to evaluate the effectiveness of three different dose levels of CIT-013 compared to placebo in people with moderately active rheumatoid arthritis.

The medication CIT-013 will be tested at various dose levels (including 50 mg and 100 mg) to determine if it can reduce disease activity. Participants in this study will continue taking their conventional synthetic disease modifying antirheumatic drug (a medication that slows the progression of rheumatoid arthritis) that they were on before joining the study.

The trial will follow participants for approximately 85 days to monitor how the medication affects their disease activity score (a measurement of arthritis symptoms and inflammation). Throughout the study, researchers will assess joint tenderness, joint swelling, and other indicators of disease activity, as well as monitor participants for any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and baseline measurements

    On your first visit after joining the study, you will undergo baseline measurements to assess your rheumatoid arthritis disease activity. This includes counting your swollen and tender joints and measuring your DAS28-CRP score (a standard measure of rheumatoid arthritis disease activity).

    You will also complete questionnaires such as the Health Assessment Questionnaire Disability Index (HAQ-DI), which evaluates how your condition affects your daily activities.

  2. Step 2

    Random assignment to treatment group

    You will be randomly assigned to receive either CIT-013 (at one of three dose levels) or placebo (0.9% Sodium Chloride solution that contains no active medication).

    Neither you nor your doctor will know which treatment you are receiving, as this is a 'double-blind' study.

  3. Step 3

    Treatment period

    You will receive the study medication (either CIT-013 or placebo) as an infusion (administered through a vein).

    You will continue taking your current conventional synthetic disease modifying antirheumatic drug (csDMARD) throughout the study, which you should have been taking for at least 3 months before joining the study.

    During the treatment period, you must use adequate contraception. If you are female, you must continue contraception for 31 weeks after your last dose. If you are male, you must continue contraception and refrain from donating sperm for 18 weeks after your last dose.

  4. Step 4

    Day 43 assessment

    On day 43 of the study, you will return to the clinic for a comprehensive assessment of your rheumatoid arthritis.

    Your doctor will measure your DAS28-CRP score again to determine if there has been any change in your disease activity.

    The doctor will also check if you've achieved an ACR20, ACR50, or ACR70 response (meaning a 20%, 50%, or 70% improvement in your symptoms according to American College of Rheumatology criteria).

    You will complete the HAQ-DI questionnaire again to assess any changes in your physical function.

    Blood samples will be taken to measure the level of the study drug in your system (pharmacokinetic levels).

  5. Step 5

    Day 85 assessment (final visit)

    On day 85, you will have your final study visit with assessments similar to day 43.

    Your DAS28-CRP score will be measured again to determine the longer-term effects of the treatment.

    The doctor will check if you've achieved disease remission (DAS28-CRP less than 2.6) or low disease activity (DAS28-CRP equal to or less than 3.2).

    You will complete the HAQ-DI questionnaire one final time.

    Throughout the entire study period, any side effects you experience will be recorded as treatment-emergent adverse events (TEAEs).

Who can join the trial?

14 criteria

  • Diagnosed with Rheumatoid Arthritis (RA) according to established medical criteria at least 3 months before screening
  • Age 18 years or older
  • Have moderately active RA with:
    • A Disease Activity Score of 3.2 or higher
    • At least 3 swollen joints
    • At least 3 tender joints
    • Elevated inflammation markers in blood tests (CRP/ESR above normal limits)
    • Currently taking a conventional synthetic disease modifying antirheumatic drug (csDMARD) - a medication that helps slow RA progression - with:
      • Stable dose for at least 4 weeks
      • Used this medication for at least 3 months
      • Body mass index (BMI) between 18 and 35 kg/m² (a measurement relating your weight to your height)
      • Willing and able to provide written informed consent
      • For women who can become pregnant:
        • Must use effective birth control during the trial and for 31 weeks after last dose
        • Must have a negative pregnancy test before starting the trial
        • Must agree not to donate eggs during the trial and for 31 weeks after last dose
        • For men:
          • Must use effective birth control and not donate sperm during the trial and for 18 weeks after last dose

Who cannot join the trial?

14 criteria

  • You have severe rheumatoid arthritis (RA) instead of moderate RA
  • You are pregnant or breastfeeding
  • You have a current infection or have had one recently
  • You have tested positive for tuberculosis (TB) or have active TB
  • You have serious liver problems
  • You have serious kidney problems
  • You have a history of cancer in the past 5 years (except for certain skin cancers that have been successfully treated)
  • You have had a heart attack, stroke, or other serious heart condition recently
  • You are currently taking certain medications that might interact with the study drug
  • You have participated in another clinical trial within the past 30 days
  • You have a history of allergic reactions to similar medications
  • You have been diagnosed with another autoimmune disease besides RA
  • You have had previous treatment that didn't work for your RA
  • You have uncontrolled high blood pressure or diabetes
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Investigated drugs

  • CIT-013

    is an investigational medication being studied for its potential to reduce disease activity in patients with moderately active rheumatoid arthritis. It is being tested to see if it can effectively decrease inflammation and improve symptoms of rheumatoid arthritis.

  • Placebo

    is an inactive substance that looks like the medication being tested but contains no active ingredients. It's used as a comparison to determine if the investigational medication actually works better than no treatment.

What is already known about the treatment

CIT-013 – This is an investigational medication currently being studied in clinical trials for the treatment of moderately active rheumatoid arthritis. It is likely administered in controlled doses to evaluate its effectiveness in reducing disease activity and inflammation in patients with this autoimmune condition. While the specific mechanism of action is not detailed in the provided information, CIT-013 is being tested at three different dose levels against a placebo to determine its efficacy. As a Phase IIa trial medication, it is still in the earlier stages of clinical development, meaning it has not yet been approved for general medical use and researchers are working to establish its safety profile and optimal dosing.

Investigated diseases

Rheumatoid Arthritis is a chronic inflammatory autoimmune disease that primarily affects the joints. The condition causes the immune system to attack the lining of the joints (synovium), leading to inflammation, pain, and swelling. Over time, this persistent inflammation can damage cartilage and bone within the joints, resulting in joint deformity and decreased mobility. Rheumatoid arthritis typically affects multiple joints symmetrically, most commonly the small joints of the hands and feet. The disease often progresses from mild to moderate and severe stages, with periods of flares (increased disease activity) alternating with periods of relative remission. Beyond joint involvement, rheumatoid arthritis can also affect other body systems, including the skin, eyes, lungs, and blood vessels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517356-35-00Protocol codeCITRYLL002-CitydreamEstimated enrolment88 patientsSponsorCitryll B.V.

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