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Clinical trial

Randomized Double Blind Phase I Trial Comparing Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Rituximab (Mabscale LLC, Russia)+ Methotrexate+ Folic Acid and MabThera® Methotrexate+ Folic Acid in Adult Patients With Moderate or Severe Rheumatoid Arthritis With Insufficient Response to Treatment Tumor Necrosis Factor (TNF-α)

NCT06175338 is registered in ClinicalTrials.gov with Mabscale, LLC as lead sponsor.

NCT NCT06175338
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Registry record

As filed in ClinicalTrials.gov.

Title
Randomized Double Blind Phase I Trial Comparing Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Rituximab (Mabscale LLC, Russia)+ Methotrexate+ Folic Acid and MabThera® Methotrexate+ Folic Acid in Adult Patients With Moderate or Severe Rheumatoid Arthritis With Insufficient Response to Treatment Tumor Necrosis Factor (TNF-α)
Lead sponsor
Mabscale, LLC
Phase
Phase 1
Overall status
Active, not recruiting
Start date
June 14, 2023
Completion date
April 30, 2025
Enrollment
208 (actual)
Sites
12

Conditions

As the registry lists them; a condition with its own page is linked.

rheumatoid arthritis