Reduction of plasma cells as an approach to reset autoimmunity in rheumatoid arthritis
Key facts
- Where
- Berlin és Erlangen, NémetországSee the 2 sites
- Phase
- 1/2. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországTaking people
- Universitaetsklinikum Erlangen AöRErlangen, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charite Universitaetsmedizin Berlin KöR
- Trial code
- EU 2024-511536-27-00
- Record updated
- 2026. október 30.
- Original description
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.Read full original descriptionShow less
Plasma cell depletion as an approach to reset autoimmunity in rheumatoid arthritis
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.
Inclusion: 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.
Exclusion: 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); 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; Planned or ongoing pregnancy or breast-feeding; Hereditary fructose intolerance (HFI).