Recruiting NCT06567470

A Study With CIT-013 in RA Patients

Phase II Interventional Rheumatoid Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: CIT-013 low dose, CIT-013 high dose, Placebo, CIT-013 medium dose.
Who it may be relevant to: Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Belgium, Germany, Netherlands, Poland, Spain
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase IIa Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Trial To Investigate The Effects Of Three Dose Levels Of CIT-013 On Disease Activity In Patients With Moderately Active Rheumatoid Arthritis.

Overview

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

Interventions

Drug CIT-013 low dose
Subcutaneous injection
Drug CIT-013 high dose
Subcutaneous injection
Drug Placebo
Subcutaneous injection
Drug CIT-013 medium dose
CIT-013 medium dose

Primary outcome measures

The change in DAS28-CRP at week 6 compared to baseline [Time frame: week 6]

Secondary outcome measures (2)

Incidence of TEAEs as assessed by CTCAE [Time frame: 12 weeks]
Maximum Plasma Concentration of CIT-013 before doses [Time frame: 4, 6, 10 and 12 weeks]

Eligibility criteria

Inclusion 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

Poland · 6 centers

PL-01 — Bialystok
PL-07 — Krakow
PL-03 — Lublin
PL-02 — Poznan
PL-05 — Torun
PL-04 — Warsaw

Spain · 6 centers

ES-02 — A Coruña
ES-04 — Barcelona
ES-05 — Barcelona
ES-06 — Madrid
ES-01 — Santander
ES-03 — Santiago de Compostela

Germany · 5 centers

DE-04 — Bamberg
DE-05 — Berlin
DE-01 — München
DE-02 — München
DE-03 — Ratingen

Netherlands · 5 centers

NL-02 — Amsterdam
NL-05 — Leeuwarden
NL-04 — Leiden
NL-03 — Nijmegen
NL-01 — Rotterdam

Belgium · 2 centers

BE-02 — Antwerp
Site BE-01 — Leuven

Identifiers

NCT: NCT06567470 · CITRYLL002

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗