Health TrialsbyHealthPanel

A Study With CIT-013 in RA Patients

ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCitryll BV

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

≥ 1 week for etanercept;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CIT-013 low dose

    Drug

    Subcutaneous injection

  • CIT-013 high dose

    Drug

    Subcutaneous injection

  • Placebo

    Drug

    Subcutaneous injection

  • CIT-013 medium dose

    Drug

    CIT-013 medium dose

Treatment groups

88 Participants
are divided into 4 treatment groups
Group A: CIT-013 low doseExperimental treatment 1 intervention
Group B: CIT-013 high doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Group D: CIT-013 medium doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The change in DAS28-CRP at week 6 compared to baseline

Efficacy of CIT-013

Time frame
week 6

Secondary outcomes

1

Incidence of TEAEs as assessed by CTCAE

Safety and tolerability of CIT-013

Time frame
12 weeks
2

Maximum Plasma Concentration of CIT-013 before doses

CIT-013 levels

Time frame
4, 6, 10 and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Citryll BV

Lead sponsor

Source ClinicalTrials.gov
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