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
- Conditions
- -M069M069
- Registration Number
- PER-022-14
- Lead Sponsor
- CELLTRION, INC.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 65
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 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 antitumor necrosis factor (TNF) agents: infliximab, golimumab, adalimumab or etanercept or was intolerant to at least 1 administration of these agents. Patients who discontinued etanercept for at least 4 weeks, infliximab or adalimumab for at least 8 weeks, or golimumab for at least 10 weeks prior to randomization are permitted to enter the study. Patients who received any other anti-TNF agents not in this list can be enrolled if the patient discontinued the treatment at least 4 weeks or 5 half-lives prior to randomization, whichever is longer.
5. Patient has a proper discontinuation period after treatment with interleukin-1 receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept. Patients who discontinued IL-1R antagonist for at least 4 weeks, abatacept for at least 8 weeks or IL-6R antibody for at least 17 weeks prior to randomization are permitted to enter the study. Patients who had any other biological drugs not in this list can be enrolled if the patient discontinued the treatment at least 4 weeks or 5 half-lives prior to randomization, whichever is longer.
6. Patient has received MTX treatment (7.5 to 25 mg/week orally or parenterally) for at least the past 12 weeks, with the last 4 weeks at a stable dose before Screening.
7. Patient has the following hematology laboratory test results: Hemoglobin ≥8.0 g/Dl, White blood cell count ≥3.5 × 103 cells/µL, Neutrophil count ≥1.5 × 103 cells/µL and Platelet count ≥75 × 103 cells/µL.
8. Patient has adequate renal and hepatic function Serum creatinine <1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula), Serum alanine aminotransferase <3 × ULN, Serum aspartate aminotransferase <3 × ULN and Serum total bilirubin <2 × ULN.
9. Patient has the ability to comprehend the full nature and purpose of the study, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study.
10. Patient (or legal guardian, if applicable) has been informed of the full nature and purpose of the study and provide signed and dated written informed consent before inclusion in the study.
11. For both male and female patients, the patient and their partners of childbearing potential either agree to practice total abstinence or use 2 of the following medically acceptable methods of contraception during the course of the study and for 12 months following discontinuation of study drug: Barrier contraceptives, Hormonal contraceptives and Intrauterine device.
Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use 2 medically acceptable methods of contraception or to practice total abstinence.
Menopausal females must have experienced their last period more than 12 months p
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 HIV-1 or -2 or who has a positive result to the screening test for these infections.
5. Patient has an infection requiring antibiotics or the patient has a history of recurrent herpes zoster or other chronic or recurrent infection.
6. Patient has a past or current diagnosis of tuberculosis (TB), recent exposure to person with active TB, examination findings indicating the presence of TB, defined as a positive result for interferon-γ release assay, or other severe or chronic infection. A patient who has a past diagnosis with sufficient documentation of prophylaxis or complete resolution following treatment can be enrolled.
7. Patient is receiving any of the following medications or therapies: IV gamma globulin or the Prosorba Column.
Any surgical procedure, including bone or joint surgery or synovectomy. Intra-articular corticosteroids. Patients are permitted to receive either oral or parenteral glucocorticoids (≤10 mg daily of prednisone/prednisolone or equivalent), and nonsteroidal anti-inflammatory drug. Disease-modifying antirheumatic drugs, other than MTX, including hydroxychloroquine, chloroquine, or sulfasalazine. Live or live-attenuated vaccine and killed vaccines. History of any biologic agent causing B-lymphocyte (B-cell) depletion or targeting B-cells.
8. Patient has a medical condition including one or more of the following:
Uncontrolled diabetes mellitus. Uncontrolled hypertension. Any other inflammatory or rheumatic disease. History of any malignancy within the previous 5 years prior to date of informed consent. History of lymphoma, lymphoproliferative disease, or bone marrow hypoplasia. Patients with New York Heart Association class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, arrhythmias, clinically significant electrocardiogram [ECG] abnormalities), or myocardial infarction within the previous 6 months prior to date of consent. History of organ transplantation, including corneal graft/transplantation. Severe physical incapacitation. Any uncontrolled clinically significant respiratory disease (in the opinion of the investigator). Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain Barre syndrome. Any condition significantly affecting the nervous system. Any other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration.
9. Patient has current or past history of drug or alcohol abuse.
10. Patient has had treatment with any other investigational device or medicinal product.
11. Patient is a female who is currently pregnant or breastfeeding or is planning to become pregnant or breastfeed within 12 months of the last dose of study drug.
12. Patient, in the opinion of their general practitioner or investigator, should not participate in the study.
13. Patient has a history of rheumatic autoimmune disease other than RA (except secondary Sjögren’s syndrome) or significant systemic involvement secondary to RA (v
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method