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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIT-013 low dose | Experimental | 3 SC injections with low dose CIT-013 and 3 SC injections with medium dose CIT-013 |
|
| CIT-013 high dose | Experimental | 3 SC injections with CIT-013 high dose and 3 SC injections with CIT-013 medium dose |
|
| Placebo | Placebo Comparator | 3 SC injections with placebo and 3 SC injections with CIT-013 medium dose |
|
| CIT-013 medium dose | Experimental | 6 SC injections with CIT-013 medium dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIT-013 low dose | Drug | Subcutaneous injection |
| |
| CIT-013 high dose |
| Measure | Description | Time Frame |
|---|---|---|
| The change in DAS28-CRP at week 6 compared to baseline | Efficacy of CIT-013 | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs as assessed by CTCAE | Safety and tolerability of CIT-013 | 12 weeks |
| Maximum Plasma Concentration of CIT-013 before doses | CIT-013 levels |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonie Middelink | Contact | 0613328444 | lmiddelink@citryll.com |
| Name | Affiliation | Role |
|---|---|---|
| Maarten Kraan | Citryll BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BE-02 | Withdrawn | Antwerp | Belgium | |||
| Site BE-01 |
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| Drug |
Subcutaneous injection |
|
| Placebo | Drug | Subcutaneous injection |
|
| CIT-013 medium dose | Drug | CIT-013 medium dose |
|
| 4, 6, 10 and 12 weeks |
| Recruiting |
| Leuven |
| Belgium |
|
| DE-04 | Recruiting | Bamberg | Germany |
|
| DE-05 | Recruiting | Berlin | Germany |
|
| DE-01 | Recruiting | München | Germany |
|
| DE-02 | Recruiting | München | Germany |
|
| DE-03 | Withdrawn | Ratingen | Germany |
| NL-02 | Withdrawn | Amsterdam | Netherlands |
| NL-05 | Recruiting | Leeuwarden | Netherlands |
|
| NL-04 | Withdrawn | Leiden | Netherlands |
| NL-03 | Not yet recruiting | Nijmegen | Netherlands |
|
| NL-01 | Recruiting | Rotterdam | Netherlands |
|
| PL-01 | Recruiting | Bialystok | Poland |
|
| PL-07 | Recruiting | Krakow | Poland |
|
| PL-03 | Recruiting | Lublin | Poland |
|
| PL-02 | Recruiting | Poznan | Poland |
|
| PL-05 | Recruiting | Torun | Poland |
|
| PL-04 | Recruiting | Warsaw | Poland |
|
| ES-02 | Recruiting | A Coruña | Spain |
|
| ES-04 | Recruiting | Barcelona | Spain |
|
| ES-05 | Recruiting | Barcelona | Spain |
|
| ES-06 | Recruiting | Madrid | Spain |
|
| ES-01 | Recruiting | Santander | Spain |
|
| ES-03 | Recruiting | Santiago de Compostela | Spain |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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