DARATUMUMAB for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Fulfilment of the 2010 ACR-EULAR criteria of rheumatoid arthritis"}
• {"criterion_text":"- ACPA positivity (above the laboratory reference level for positivity)"}
• {"criterion_text":"- Disease activity score DAS28-ESR >3.2"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Fulfilment of the requirements for the administration of abatacept as stated in the abatacept SmPC"}

Exclusion criteria

• {"criterion_text":"- Planned or ongoing pregnancy or breast-feeding"}
• {"criterion_text":"- Hypersensitivity to the IMP, severe and uncontrolled infections such as sepsis and opportunistic infections"}
• {"criterion_text":"- Severe and uncontrolled infections such as sepsis and opportunistic infections"}
• {"criterion_text":"- Hereditary fructose intolerance (HFI)"}
• {"criterion_text":"- Vaccination with attenuated vaccines during the course of the study"}
• {"criterion_text":"- Ongoing or previous treatment with daratumumab"}
• {"criterion_text":"- Concomitant treatment with other bDMARDs and/or tsDMARDs"}
• {"criterion_text":"- Concomitant treatment with high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)"}
• {"criterion_text":"- Concomitant treatment with high-dosed glucocorticoids (>30 mg prednisolone equivalent per day except for daratumumab premedication)"}
• {"criterion_text":"- Active ongoing inflammatory diseases other than RA"}
• {"criterion_text":"- Malignant disease or history of malignant disease within 5 years prior to screening"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- History of known chronic obstructive pulmonary disease (COPD: severity I-IV, bronchial asthma: severity 2-4)"}
• {"criterion_text":"- Prior primary non-response or intolerance to abatacept or treatment with abatacept within the last 6 months before baseline"}

Primary endpoints

• {"endpoint_text":"- Incidence and grading of severity of Injection Related Reactions (IRR) and toxicity after administration of daratumumab until week 12","definition_or_measurement_approach":"Incidence and grading of IRR and toxicity recorded after daratumumab administration with observation period up to week 12."}
• {"endpoint_text":"- AE and SAE due to IMP (both, daratumumab and abatacept) throughout the whole study","definition_or_measurement_approach":"Adverse events (AE) and serious adverse events (SAE) causally related to investigational medicinal products collected and recorded throughout the entire study duration."}
• {"endpoint_text":"- Percentage of subjects with ACPA seroconversion (below the laboratory reference level for positivity)","definition_or_measurement_approach":"Proportion of subjects whose ACPA levels fall below the laboratory reference level for positivity (ACPA seroconversion) as determined by the laboratory assay."}

Germany

Earliest CTIS Part Ii Submission Date

22-02-2024

Latest Decision Or Authorization Date

29-11-2024

Processing Time Days

281

Number Of Sites

2

Number Of Participants

23

Primary sponsor

Full Name

Charite Universitaetsmedizin Berlin KöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany