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

• Register: EUCTR
• Last refreshed on: 21 October 2013
• Main ID: EUCTR2011-004468-31-LT
• Date of registration: 05/01/2012
• Prospective Registration: Yes
• Primary sponsor: CELLTRION, Inc
• Public title: Evaluating the long-term Safety and Efficacy effects of CT-P13 together with methotrexate in patients with arthritis
• Scientific title: An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1
• Date of first enrolment: 14/03/2012
• Target sample size: 617
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004468-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Austria, Bosnia and Herzegovina, Bulgaria, Chile, Colombia, Italy, Latvia, Lithuania, Mexico, Peru, Philippines, Poland, Portugal, Romania, Slovakia, Spain, Ukraine, United Kingdom

Contacts

• Name: Regulatory Affairs
• Affiliation: CELLTRION, Inc

• Name: Regulatory Affairs
• Affiliation: CELLTRION, Inc

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Rheumatoid Arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

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-

Primary Outcome(s)

Main Objective: To confirm long-term efficacy and safety of CT-P13.

Primary end point(s): Efficacy endpoint evaluations are:
• Individual components of the ACR criteria comparison with baseline of Study CT-P13 3.1 at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102)
• Mean decrease in disease activity measured by DAS28 comparison with baseline of Study CT-P13 3.1 at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102)
• Proportion of patients with a good response defined according to the EULAR response criteria at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102)
• Proportion of patients achieving ACR20, ACR50, and ACR70 at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102)
• Hybrid ACR response at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102)
• Joint damage progression at Week 102 (or the End-of-Study Visit if not obtained at Week 102)
• Number of patients requiring salvage retreatment at Week 102 (or the End-of-Study Visit if not obtained at Week 102)

The safety endpoint evaluations are:
• Immunogenicity at Weeks 78 and 102 (or the End-of-Study Visit if not obtained at Week 102)
• Vital sign measurements
• ECG findings at Week 102 (or the End-of-Study Visit if not obtained at Week 102)
• Interferon-? release assay
• Physical examination findings
• Clinical laboratory tests including urine pregnancy, ESR, and CRP tests
• AEs including SAEs
• Concomitant medications
• Signs and symptoms of TB
• Infections
• Infusion-related reactions
• Malignancies
• Hypersensitivity via vital sign monitoring

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: Efficacy will be evaulated at: week 78, 102 and 110
Safety will be evaulated at: week 62. 70, 78, 86, 94, 102 and 110

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

2011-004468-31-GB

CT-P13-3.2

Source(s) of Monetary Support

CELLTRION, Inc