A Randomized, Parallel-Group, Phase I/III Study to Evaluate Efficacy, Pharmacokinetics and Safety between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: -M069; Cholera, unspecified; A009; M069

• Registration Number: PER-015-17
• Lead Sponsor: A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-11
• Study Completion: 2019-01-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

Male or female patients with active RA who are not adequately responding to methotrexate administration over at least 3 months, will be considered for enrolment in the study if they meet all of the inclusion criteria and none of the exclusion criteria.
1.Patient is male or female (18 to 75 years old inclusive).
2.Patient has a diagnosis of RA according to the 2010 ACR/EULAR classification criteria [Aletaha et al. 2010] for at least 6 months prior to the first administration of the study drug (Day 0).
3.Patient has active disease as defined by the presence of 6 or more swollen joints (of 28 assessed), 6 or more tender joints (of 28 assessed), and a serum CRP concentration > 0.6 mg/dL at Screening. Unexplained or unexpected Screening CRP value that does not match the clinical activity of RA according to the investigator’s assessment or recent test can be retested once within the Screening period.
4.Patient who has 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 the first administration of the study drug (Day 0).
5.Patient has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results:
•Serum creatinine <1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula)
•Serum alanine aminotransferase <2.5 × ULN
•Serum aspartate aminotransferase <2.5 × ULN
•Serum total bilirubin <2 × ULN
6.Patient has the following hematology laboratory test results at Screening:
5.Hemoglobin ≥8.5 g/dL (SI [Système International d´Unites] units: ≥85 g/L or 5.28 mmol/L)
6.White blood cell count ≥3.5 × 103 cells/µL (SI units: ≥3.5 × 109 cells/L)
7.Neutrophil count ≥1.5 × 103 cells/µL (SI units: ≥1.5 × 109 cells/L)
8.Platelet count ≥100 × 103 cells/µL (SI units: ≥100 × 109 cells/L)
7.Patient has 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/or written instructions, and to comply with the requirements of the entire study.
8.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 or understand this information, signed and dated the written informed consent before inclusion in the study.
9.For both male and female patients, the patient and their partners of childbearing potential agree to use one of the following medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug (excluding women who are not of childbearing potential and men who have been sterilized):
•Barrier contraceptives (male condom, female condom, or diaphragm with a spermicidal gel)
•Hormonal contraceptives (implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings)
•Intrauterine device
Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any medically acceptable methods of contraception.
•Menopausal females must

Exclusion Criteria

The exclusion criteria are divided into 2 categories: tuberculosis exclusion criteria and general exclusion criteria. Patients meeting any of the following criteria will be excluded from the study:
Tuberculosis Exclusion Criteria
1.Patient who has a history of tuberculosis (TB) or a current diagnosis of TB. A patient who has a past diagnosis of active TB with sufficient documentation of complete resolution can be enrolled.
2.Patient who has had exposure to person with active TB such as first degree family members or co-workers.
3.Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent TB (defined as a positive result of IGRA with a negative examination of chest x-ray) at Screening. A patient who has a past diagnosis of latent TB with sufficient documentation of prophylaxis can be enrolled.
For Part 2, if the result of the IGRA is indeterminate at Screening, 1 retest will be possible during the screening period. If the repeated IGRA result is again indeterminate, the patient must be excluded from the study. If the repeated IGRA result is negative, the patient can be included in the study.
A patient with a confirmed latent TB during Screening who has received at least the first 30 days of country-specific TB therapy and intends to complete the entire course of that therapy can be enrolled.
General Exclusion Criteria
1.Patient who has previously received a biological agent for the treatment of RA and/or a TNFα inhibitor for the treatment of other disease.
2.Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.
3.Patient who has a current or past history of following infection:
Current or past history of chronic infection with hepatitis C or human immunodeficiency virus-1 or -2 or current infection with hepatitis B
Acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug (Day 0)
Other serious infection within 6 months prior to the first administration of the study drug (Day 0)
Recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug (Day 0)
Past or current granulomatous infections or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, or invasive fungal infection such as histoplasmosis). A patient who has a past diagnosis with sufficient documentation of complete resolution can be enrolled
4.Patient who has a medical condition including one or more of the following:
Classified as obese (body mass index ≥35 kg/m2)
Uncontrolled diabetes mellitus, even after insulin treatment
Uncontrolled hypertension (as defined by systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg)
Any other inflammatory or rheumatic diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, 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 5 years prior to the first administration of the study drug (Day 0)except completely excised and c

Study & Design

• Study Type: Interventional
• Study Design: Not specified