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Taking people in GermanyPhase 1/2

Testing abatacept with daratumumab in adults with rheumatoid arthritis

Tests abatacept plus daratumumab for safety and effect in adults with rheumatoid arthritis.

Key facts

Who runs it
Charite Universitaetsmedizin Berlin KöR
Where
Berlin and Erlangen, GermanySee the 2 sites
Registry title
Reduction of plasma cells as an approach to reset autoimmunity in rheumatoid arthritis
Status
Recruiting
Phase
Phase 1/2
People taking part
23 people, planned
Started
11 Mar 2025
Expected to end
31 Aug 2027
Type of study
Interventional
Record updated
30 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with rheumatoid arthritis who test positive for ACPA and whose disease is still active despite earlier treatment. It tests abatacept together with daratumumab.

Age
18 years or older
Sex
Men and women can join
Disease stage
Rheumatoid arthritis meeting the 2010 ACR-EULAR criteria, with active disease (DAS28-ESR above 3.2)
Earlier treatment
Must have had too little response to, or could not tolerate, at least one csDMARD (for example MTX) and/or bDMARD or tsDMARD. Only MTX may be taken with the study drugs; sulfasalazine, hydroxychloroquine and leflunomide must be stopped and replaced by MTX during screening.
Biomarker or test result
ACPA positive (above the laboratory reference level)

Main reasons for not taking part

  • Pregnant, planning pregnancy or breast-feeding
  • Other active inflammatory disease, or cancer within the last 5 years
  • Chronic infection such as untreated latent TB, HIV, or active or past hepatitis B or C
  • Earlier or current treatment with daratumumab, or abatacept in the last 6 months or without response
  • Taking other bDMARDs or tsDMARDs, or high-dose glucocorticoids (above 30 mg prednisolone equivalent per day)

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Germany

  • Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
  • Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Plasma cell depletion as an approach to reset autoimmunity in rheumatoid arthritis
Plain-language title
Testing abatacept with daratumumab in adults with rheumatoid arthritisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
30 October 2026