Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis

Conditions: Rheumatoid Arthritis
MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2011-004468-31-PL

Lead Sponsor: CELLTRION, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 617

Inclusion Criteria

1 Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 3.1.
2 Patient who has not had any major protocol violation in Study CT-P13 3.1.
3 Patient is permitted to enter the extension study if, in the opinion of their general practitioner or the investigator, the patient will continue to gain benefit from treatment in the extension study. Local guidelines for patient treatment will be followed.
4 Patient (or legal guardians, 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, and has signed and dated the written informed consent before inclusion in the extension study.
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 treatment (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.
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 417
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1 Patient who has been withdrawn from Study CT-P13 3.1 for any reason.
2 Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events (SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the opinion of the investigator.
3 Patient who plans to participate in a study with an investigational drug during the period of this extension study.
4 Female patient who is planning to become pregnant or breastfeed within the period of this study.
5 Patient who plans to receive a live or live-attenuated vaccination or who is scheduled to receive a live or live-attenuated vaccination during the period of this study. Killed vaccines are acceptable during the study.
6 Patient who, in the opinion of their general practitioner or investigator, should not participate in this extension study for whatever reason.
7 Patient who is receiving any surgical procedure, including bone or joint surgery or synovectomy (including joint fusion or replacement) within 12 weeks prior to the time of providing informed consent or planned within 6 months after the time of providing informed consent.
8 Patient who, at the time of providing informed consent, is taking, is planning to take, or is required to take during the course of this study any of the following concomitant medications:
• Corticosteroids, except oral glucocorticoids, of maximum equivalent daily dose of 10 mg of prednisolone. (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.)
• Disease-modifying antirheumatic drugs, other than methotrexate, including hydroxychloroquine, chloroquine, sulfasalazine, or leflunomide.
• Alkylating agents
• Live or live-attenuated vaccines
• Any biological agents for the treatment of RA except CT-P13 or Remicade
9. Patient who had any of the following: Infection requiring oral antibiotics within 2 weeks prior to the time of providing informed consent; parenteral injection of antibiotics within 4 weeks before the time of providing informed consent; other serious infection in the 6 months before the time of providing informed consent; or history of recurrent herpes zoster or any other chronic or recurrent infection