2024-511536-27-00RecruitingPhase 1/2
Reduction of plasma cells as an approach to reset autoimmunity in rheumatoid arthritis
Plasma cell depletion as an approach to reset autoimmunity in rheumatoid arthritis
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Oct 2026
Brief summary (registry, in English)
To assess the safety of combined abatacept/daratumumab treatment in ACPA-positive RA subjects. To assess the clinical efficacy of combined abatacept/daratumumab treatment in ACPA-positive RA subjects.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 22 Feb 2024
- Start date
- 11 Mar 2025
- Lead sponsor
- Charite Universitaetsmedizin Berlin KöR
- Diseases
- Rheumatoid arthritis
- EU CT number
- 2024-511536-27-00
- EudraCT number
- 2021-006669-40
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 23
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior primary non-response or intolerance to abatacept or treatment with abatacept within the last 6 months before baseline
- Vaccination with attenuated vaccines during the course of the study
- Ongoing or previous treatment with daratumumab
- Concomitant treatment with other bDMARDs and/or tsDMARDs
- Concomitant treatment with high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
- Concomitant treatment with high-dosed glucocorticoids (>30 mg prednisolone equivalent per day except for daratumumab premedication)
Other illness
- Active ongoing inflammatory diseases other than RA
- Malignant disease or history of malignant disease within 5 years prior to screening
- Chronic infection such as latent TB (not adequately treated according to guidelines), HIV infection or active hepatitis B, C or history of hepatitis B, C
- History of known chronic obstructive pulmonary disease (COPD: severity I-IV, bronchial asthma: severity 2-4)
- Hypersensitivity to the IMP, severe and uncontrolled infections such as sepsis and opportunistic infections
- Severe and uncontrolled infections such as sepsis and opportunistic infections
Other
- Planned or ongoing pregnancy or breast-feeding
- Hereditary fructose intolerance (HFI)
Who the study is looking for
- Fulfilment of the 2010 ACR-EULAR criteria of rheumatoid arthritis
- ACPA positivity (above the laboratory reference level for positivity)
- Disease activity score DAS28-ESR >3.2
- Inadequate treatment response and/or intolerance to at least one csDMARD (e.g. MTX) and/or bDMARDs (e.g. TNF-alpha inhibitors or IL-6 blockers or tsDMARDs)
- csDMARD: only simultaneous therapy with MTX (if tolerated) allowed, i.e. Sulfasalazin, Hydroxychloroquine and Leflunomide must be stopped during screening phase and be replaced by MTX
- Women of childbearing potential (WOCBP) must use adequate effective methods of contraception during participation in the study and 3 months after the last dose of Daratumumab or 14 weeks after the last dose of Abatacept
- Fulfilment of the requirements for the administration of abatacept as stated in the abatacept SmPC
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Recruiting |
| Universitaetsklinikum Erlangen AöR | Erlangen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.