A Randomized, Double Blind, Parallel-Group, Phase 3 Study to Demonstrate Equivalence in Efficacy and Safety of CT-P13 Compared With Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis - ND

• Conditions: Rheumatoid Arthritis; MedDRA version: 9.1Level: LLTClassification code 10039073

• Registration Number: EUCTR2010-018646-31-IT
• Lead Sponsor: CELLTRION, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-26
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 584

Inclusion Criteria

1. Patient is male or female aged 18 to 75 years old, inclusive. 2. Patient was diagnosed with active RA according to the revised 1987 ACR classification criteria [Arnett et al 1987] for at least 1 year prior to Screening. 3. Patients have active disease as defined by the presence of 6 or more swollen joints, and 6 or more tender joints, and at least two of the following: morning stiffness lasting at least 45 minutes, an erythrocyte sedimentation rate greater than 28 mm/h, and a serum C reactive protein (CRP) concentration greater than 2.0 mg/dL (Maini et al 1999). 4. Patients who have completed at least 3 months of treatment of oral or parenteral dosing with methotrexate between 12.5 to 25 mg/week and on stable dosing with methotrexate between 12.5 to 25 mg/week for at least 4 weeks prior to Screening. 5. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (eg, barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings), and intrauterine devices) during the course of the study and for 6 months following discontinuation of study treatments (excluding women who are not of childbearing potential and men who have been sterilized). 6. Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to study entry must agree to use 2 medically accepted methods of contraception as per inclusion criterion 5. 7. Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential. 8. Patients have adequate renal and hepatic function at Screening as defined by the following clinical chemistry results: • Serum creatinine <1.7 ? upper limit of normal (ULN) or an estimated creatinine clearance level >75 mL/min • Serum alanine aminotransferase <2 ? ULN • Serum aspartate aminotransferase <2 ? ULN 9. Patients are permitted to receive both oral glucocorticoids equivalent to =10 mg daily prednisolone and nonsteroidal anti-inflammatory drugs, if they have received a stable dose for at least 4 weeks prior to Screening. 10. Patients have the ability to comprehend the full nature and purpose of the study, including possible risks and side effects, to cooperate with the investigator, to understand verbal and written instructions, and to comply with the requirements of the entire study. 11. Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information, signed and dated the written informed consent before inclusion in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who have previously been administered a biological agent for the treatment of RA. 2. Patients who have allergies to any of the excipients of infliximab or any other murine and human proteins. 3. Patients who have a current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus 1 or 2 or who have a positive result to the screening test for those infections. 4. Patients who have a current diagnosis of tuberculosis (TB) or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, or invasive fungal infection such as histoplasmosis) or a past diagnosis without sufficient documentation of complete resolution following treatment. 5. Patients who have had recent exposure to persons with active TB, or who have a positive result to the screening test for latent TB defined as a positive result of interferon-? release assay with a negative examination of chest x-ray, and who have not received at least the first 30 days of country-specific TB therapy and do not intend to complete the entire course of that therapy. 6. Patients who have had any other serious infection not already excluded in the 6 months before Screening or with a history of chronic infection. 7. Patients who have a current or past history of drug or alcohol abuse. 8. Patients who have a medical history including one or more of the following conditions: • Bone marrow hypoplasia • Diabetes mellitus unless on a stable dosing regimen for at least 4 weeks prior to Screening; patients must maintain stable dosing throughout the study • Any other inflammatory rheumatic disease and other chronic painful musculoskeletal or neuropathic conditions such as fibromyalgia • Any malignancy within the previous 5 years except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or squamous cell carcinoma • Congestive heart failure (NYHA Class III/IV) or unstable angina • Organ transplantation • Severe physical incapacitation • Moderate, severe or very severe COPD according to the GOLD criteria • Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain Barre syndrome • Any condition significantly affecting the nervous system (ie, nervous system damage) if it may interfere with the investigator’s assessment on disease activity scores including joint counts) • Patients with seizure disorder 9. Patients taking any of the following concomitant medications: • Corticosteroids except oral glucocorticoids of maximum equivalent daily dose of 10 mg of prednisolone within 4 weeks prior to Screening • Disease-modifying antirheumatic drugs, other than methotrexate, within 4 weeks prior to Screening. Patients who discontinued leflunomide and have had successful chelation with 8 g of cholestyramine (3 times daily)for 11 days must wait 4 weeks prior to Screening. Patients who discontinued leflunomide and did not have cholestyramine washout must wait 12 weeks after last dose leflunomide before Screening. • Alkylating agents within 12 months prior to Screening 10. Patients who have participated in a study with an investigational drug within 6 months of Screening or who are currently receiving treatment with any other investigational drug or device. 11. Female patients who are currently pregnant or breastfeeding, or are planning to become pregnant or breastfeed within 6 months of the la

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified