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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 25 September 2012
Main ID:  EUCTR2010-018646-31-LV
Date of registration: 29/06/2010
Prospective Registration: Yes
Primary sponsor: CELLTRION, Inc
Public title:
Scientific title: 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 -
Date of first enrolment: 11/10/2010
Target sample size: 633
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018646-31
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Austria Bulgaria Italy Latvia Lithuania Portugal Spain United Kingdom
Contacts
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Key inclusion & exclusion criteria
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 have the following hematology laboratory test results at Screening:
• Hemoglobin =8.0 g/dL
• White blood cell count =3.5 × 103 cells/µL (SI: =3.5 × 109 cells/L)
• Neutrophil count =1.5 × 103 cells/µL (SI: =1.5 × 109 cells/L)
• Platelet count =100 × 103 cells/µL (SI: =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 ran

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 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. 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 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 (PsA), AS, spondyloarthritis, systemic lupus erythematosus, Lyme disease, or fibromyalgia, that may confound the evaluation of the effect of the 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 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, have 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 condition 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, which may increase the risk associated with study participation or investigational product administration, or that may interfere with the interpreta


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 12.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis
Intervention(s)

Product Name: CT-P13
Product Code: CT-P13
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Infliximab
CAS Number: 170277-31-3
Current Sponsor code: CT-P13
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: Remicade
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: The primary objective of this study is to demonstrate that CT P13 is equivalent to Remicade up to Week 30, in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20).
Primary end point(s): The primary efficacy endpoint will be the proportion of patients achieving clinical response according to the ACR20 criteria at Week 30. A patient is defined as a responder according to ACR20 criteria if the following are fulfilled:
•A decrease of at least 20% in the number of tender joints
•A decrease of at least 20% in the number of swollen joints and
•A 20% improvement in three of the following:
•Patient’s assessment of pain on the VAS
•Patient and physician global assessment of disease status (VAS)
•Health assessment questionnaire estimate of physical ability
•Serum CRP concentration
•ESR

The VAS range is from 0 to 100 mm, with higher scores indicating poorer status or more severe pain.

For the derivation of ACR20 at Week 30 the following categories of patients are considered nonresponders:
•Patients with an improvement according to the ACR criteria of less than 20%
•Patients who discontinue the study prior to Week 30 except for safety reasons
•Patients with missing or incomplete data for the evaluation of ACR20 at Week 30
•Patients with protocol prohibited changes in medication including initiation therapy with a new DMARD, increase in dose of RA medication (methotrexate or corticosteroid) and administration of intra articular corticosteroids in more than 1 joint
•Patients requiring a surgical joint procedure during the study

This approach should also be used for other time points where ACR20 is derived.
Secondary Objective: The secondary objectives of this study are to evaluate long term efficacy, pharmacokinetics, pharmacodynamics, and overall safety of CT P13 in comparison with Remicade reference product up to Week 54.
Secondary Outcome(s)
Secondary ID(s)
CT-P13-3.1
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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