None listed
Conditions
Interventions
Group 1 Type of group
CT-PI3 (3 mg / kg) administered as an infusion of 2 hours per dose co-administered with methotrexate between 12.5 and 25 mg / week, oral dose and folic acid (> 5 mg / week, oral dose)
Group name:Group 2 Type of group
The remicade reference product (3 mg / kg) administered as an infusion of 2 hours per dose co-administered with methotrexate between 12.5 to 25 mg / week, oral or parenteral dose and folic acid > 5 mg / week, oral dose)
Sponsors
Celltrion, Inc.,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • The patient is male or female between 18 and 75 years of age, inclusive. • The patient was diagnosed with active RA according to the revised ACR 1987 classification criteria [Amett et al 1987] for at least 1 year before Selection. • Patients have an active disease defined by the presence of 6 or more inflamed joints, and 6 or more painful joints, and at least two of the following: morning stiffness that lasts at least 45 minutes, and an erythrocyte sedimentation rate of more than 28 mm / h, and a serum C-reactive protein (CRP) concentration of more than 2.0 mg / dL [Maini et al 1999]. • Patients who completed at least 3 months of oral or parenteral dosing treatment with methotrexate between 12.5 and 25 mg / week and in a stable dose with methotrexate between 12.5 and 25 mg / week for at least 4 weeks before Selection. • Both male and female patients and their partners with reproductive capacity must agree to use at least 2 medically accepted contraceptive methods (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 6 months after discontinuation of the study treatments (excluding women who are not of reproductive age and men who have been sterilized ). • Patients both men and women and their partners who have been surgically sterilized for less than 6 months before entering the study must agree to use 2 medically accepted contraceptive methods in accordance with the inclusion criteria 5. • Menopausal women must have had their last period more than 12 months before entering the study to be classified as without reproductive potential. • Patients have adequate renal and hepatic functions in the Selection as defined in the following clinical chemistry results: Serum creatinine 75 mL / min, Alanine serum aminotransferase <2 x ULN, Aspartate aminotransferase in serum <2 x ULN • Patients are allowed to receive oral glucocorticoids equivalent to <10 mg daily of prednisolone and non-steroidal anti-inflammatory drugs, if they have received a stable dose for at least 4 weeks before Selection. • Patients have the ability to understand the 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 meet the requirements of the entire study. • The patient (or legal representative, if applicable) is informed of the nature and purpose of the study, including possible risks and side effects, and is given time and the opportunity to read and understand this information, sign and date the written informed consent before inclusion in the study.
Exclusion criteria
Exclusion criteria: • Patients who have previously received a biological agent for the treatment of RA. • Patients who have allergies to any of the excipients of infliximab or any other murine or human protein. • 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 had a positive test result for those infections. • Patients who have a current diagnosis of tuberculosis (TB) or other chronic or severe 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 after treatment. • Patients who had a recent exposure to people with active TB, or who had a positive result to the screening test for latent TB defined as a positive result of the interferon-release test and with a negative evaluation of thoracic radiography, and who did not They have received at least the first 30 days of TB therapy specific to each country and do not intend to complete the entire course of that therapy. • Patients who have had another serious infection that has not been excluded in the 6 months before the Selection or with a history of chronic infection. • Patients who have a current or past history of drug or alcohol abuse. • Patients who have participated in a study with a research drug in the last 6 months prior to the Selection or who have been receiving treatment with any other investigational drug or device. • Female patients who are pregnant or breastfeeding, or plan to become pregnant or breastfeed within 6 months after the last dose of CT-PI3 or the Remicade reference product. • Patients who received a live or live-attenuated vaccine within 8 weeks of the Selection or who are scheduled to receive a live or live-attenuated vaccine. Dead vaccines are acceptable during the study. • Patients, who in the opinion of their general practitioner or the researcher, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:AUC: Area under the co-concentration-time curve during the dosing interval, in a stable state between Week 22 and Week 30. Cmax: Maximum serum concentration observed in a stable state between Week 22 and Week 30. Measure:PK equivalence to remicade Timepoints:week 22 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The ASAS20 and ASAS40 are calculated using the following assessments: • Overall patient evaluation • Spine pain • Function according to BASFI • Morning stiffness determined using the last 2 questions of the BASDAl Measure:Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria Timepoints:at week 14, 30 and 54 ; Outcome name:The ASAS20 and ASAS40 are calculated using the following assessments: • Overall patient evaluation • Spine pain • Function according to BASFI • Morning stiffness determined using the last 2 questions of the BASDAl Measure:Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria Timepoints:at week 14, 30 and 54 ; Outcome name:Index of Bath for Ankylosing Spondylitis as well as thoracic expansion [Sieper et al 2009] are measurements of the signs and symptoms of the disease, (pain, stiffness in the spine), mobility in the spine, and physical function. Measure:Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline Timepoints:at week 14, 30 and 54 | — |
Countries
Korea South, Peru
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed