Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments ct-p10, rituxan, mabthera
Phase phase 3
Target CD20
Sponsor Celltrion
Start date May 2014
End date January 2017
Trial size 300 participants
Trial identifier NCT02149121, 2013-004555-21, CT-P10 3.2

Summary

This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
rituximab, CT-P10(experimental drug), 1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
rituxan rituximab
1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
mabthera rituximab
1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
(Active Comparator)
1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
ct-p10 MabThera
1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
mabthera rituximab
1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
(Active Comparator)
1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
ct-p10 MabThera
1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
rituxan rituximab
1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion

Primary Outcomes

Measure
Pharmacokinetics
time frame: over the first 24 weeks

Secondary Outcomes

Measure
Efficacy parameter
time frame: at Week 24

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: 1. Patient is male or female between 18 and 75 years old, inclusive. 2. 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. 3. 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. 4. Patient has experienced an inadequate response to previous or current treatment with the anti-TNF agents infliximab 5. Patient has a proper discontinuation period after treatment with interleukin-1 receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept. Exclusion Criteria: 1. Patient has taken more than 2 biologic agents. 2. Patient has previously been administered Rituximab or participated in a Rituximab biosimilar study. 3. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins. 4. 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. 5. 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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Celltrion.