PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis
This trial is active, not recruiting.
|Treatments||ct-p10, rituxan, mabthera|
|Start date||May 2014|
|End date||February 2017|
|Trial size||300 participants|
|Trial identifier||NCT02149121, 2013-004555-21, CT-P10 3.2|
This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis.
|Intervention model||parallel assignment|
|Masking||participant, care provider, investigator, outcomes assessor|
time frame: over the first 24 weeks
time frame: at Week 24
All participants from 18 years up to 75 years old.
- Patient is male or female between 18 and 75 years old, inclusive.
- Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1988) for at least 6 months prior to randomization.
- Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL (≥15 mg/L) or an ESR ≥28 mm/hour.
- Patient has experienced an inadequate response to previous or current treatment with the anti-TNF agents infliximab
- Patient has a proper discontinuation period after treatment with interleukin-1 receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept.
- Patient has taken more than 2 biologic agents.
- Patient has previously been administered Rituximab or participated in a Rituximab biosimilar study.
- Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
- Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.
- Patient has an infection requiring oral antibiotics 2 weeks before randomization, parenteral injection of antibiotics 4 weeks before randomization, other serious infection 6 months before randomization, a history of recurrent herpes zoster or other chronic or recurrent infection 6 weeks before randomization.
|Official title||A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis|
|Principal investigator||DaeHyun Yoo, M.D., Ph.D|
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