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

• Conditions: Rheumatoid Arthritis; MedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis; MedDRA version: 12.1Level: PTClassification code 10039073Term: Rheumatoid arthritis

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-22
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 633

Inclusion Criteria

1. Patient is male or female aged 18 to 75 years old, inclusive.
2. Patient was diagnosed with RA according to the revised 1987 ACR classification criteria [Arnett et al 1988] for at least 1 year prior to Screening.
3. Patients have active disease as defined by the presence of 6 or more swollen joints, 6 or more tender joints, and at least two of the following: morning stiffness lasting at least 45 minutes, an ESR greater than 28 mm/h, and a serum 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 have the following hematology laboratory test results at Screening:
•Hemoglobin =8.0 g/dL
•White blood cell count =3.5 × 103 cells/µL (SI [Système International d’Unités] units: =3.5 × 109 cells/L)
•Neutrophil count =1.5 × 103 cells/µL (SI units: =1.5 × 109 cells/L)
•Platelet count =100 × 103 cells/µL (SI units: =100 × 109 cells/L)
10. Patients are permitted to receive both oral glucocorticoids equivalent to =10 mg daily prednisolone and NSAIDs, if they have received a stable dose for at least 4 weeks prior to Screening. In addition, patients are permitted to receive low potency topical, otic, and ophthalmic glucocorticoid preparations provided the preparations are administered per the instructions on the product label.
11. 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.
12. 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 Elderl

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, and patients with a hypersensitivity to immunoglobulin product.
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 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. Patients with an abnormal chest x-ray must be discussed with the medical monitor before randomization.
6. Patients who have had an infection requiring oral antibiotics in the 2 weeks before Screening, parenteral injection of antibiotics in the 4 weeks before Screening, or other serious infection in the 6 months before Screening or who have a history of recurrent herpes zoster or other chronic or recurrent infection.
7. Patients who have a current or past history of drug or alcohol abuse.
8. Patients who have a medical condition including one or more of the following:
•Classified as obese
•Bone marrow hypoplasia
•Diabetes mellitus unless on a stable dosing regimen for at least 4 weeks prior to Screening
•Hypertension at Screening
•Any other inflammatory or rheumatic diseases, including but not limited to psoriatic arthritis, AS, spondyloarthritis, systemic lupus erythematosus, Lyme disease, or fibromyalgia, that may confound the evaluation of the effect of study drug
•History of any malignancy within the previous 5 years except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma
•History of lymphoma or lymphoproliferative disease
•History of congestive heart failure (New York Heart Association [NYHA] class III/IV) or unstable angina
•History of organ transplantation
•History of severe hypersensitivity
•Severe physical incapacitation (unable to perform routine self care, has RA ACR functional status class 4 [Arnett et al 1988], or who cannot benefit from medication)
•Any clinically significant respiratory disease, including but not limited to chronic obstructive pulmonary disease, asthma, bronchiectasis, or pleural effusion.
•Previous diagnosis or symptoms suggestive of demyelinating disorders, including multiple sclerosis and Guillain-Barre syndrome
•Any conditions significantly affecting the nervous system (ie, neuropathic conditions or nervous system damage) if it may interfere with the investigator’s assessment on disease activity scores including joint counts
•Any other serious acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that may interfere with the interpretation of study results.
9. Pat

Study & Design

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