An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of Remsima™ in Patients With Rheumatoid Arthritis

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis

Detailed Description

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of RemsimaTM in patients with RA in comparison with patients receiving non-biologic treatmentsor other anti-TNF drugs. For the RemsimaTM cohort data will be collected for patients who commence treatment with RemsimaTM in accordance with the product label at the time of enrolment (3 mg/kg of RemsimaTM by IV infusion at weeks 0, 2, 6 (±3 days) and every 8 weeks (±14 days) thereafter). For patients who have been treated with Remicade® prior to enrolment, their dosing schedule will be continued appropriately. This observational study allows drug switching between anti-TNF drugs. If switched to RemsimaTM, data will be collected until the end of study for each patient. If switched to other anti-TNF drugs (infliximab (Remicade®), etanercept, adalimumab and etc.), data will be collected until 1 year from the day of switch or until the end of study for each patient, whichever reaches earlier.

• Study Type: Observational
• Enrollment (Actual): 248

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • Recruiting
    • SungHawn Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will consist of at least 950 male and female patients with Rheumatoid Arthritis

Description

Inclusion Criteria:

1. Adult patients
2. Patients with active RA diagnosed according to the revised 1987 ACR or 2010 ACR/EULAR classification criteria

Exclusion Criteria:

1. Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins.
2. Patients with a current or past history of chronic infection
3. Patients with moderate or severe heart failure (NYHA class III/IV).

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort
Remsima™; Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.
Other Anti-TNF; Following patients were included in other anti-TNF group.; Patients who have received only anti-TNF other than Remsima or Remicade; Patients who switched from non-biologic treatment to anti-TNF other than Remsima or Remicade; Patients who switched from biologic treatment other than anti-TNF before study enrolment to anti-TNF other than Remsima or Remicade
Switch to Remsima I; Patients who switched from Remicade to Remsima were included in this analysis group.
Switch to Remsima II; Patients who switched to Remsima from biologic treatment other than Remicade were included in this analysis group.
Remicade; Patients who have received only Remicade or switched from non-biologic treatment to Remsima were included in this analysis group.
Switch to Remicade I; Patients who switched from Remsima to Remicade were included in this analysis group.
Switch to Remicade II; Patients who switched to Remicade from biologic treatment other than Remsima will be included in this analysis group.
Switch to Other Anti-TNF; Patients who switched from Remsima or Remicade to other anti-TNF other than Remicade will be included in this analysis group
Biologic Naïve; Patients who received only non-biologic treatment will be included in this analysis group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number and Percentage of Patients With the Following Adverse of Events of Special Interest (ESI)	Hepatitis B virus reactivation; Congestive heart failure; Opportunistic infections (excluding tuberculosis); Serious infections including sepsis (excluding opportunistic infections and tuberculosis); Tuberculosis (TB); Serum sickness (delayed hypersensitivity reactions); Haematological reactions; Systemic lupus erythematosus/lupus-like syndrome; Demyelinating disorders; Lymphoma (not hepatosplenic T cell lymphoma); Hepatobiliary events; Hepatosplenic T cell lymphoma (HSTCL); Serious infusion reactions during a re-induction regimen following disease flare; Sarcoidosis/sarcoid-like reactions; Leukaemia; Malignancy (excluding lymphoma); Skin cancer; Pregnancy exposure; Infusion reactions associated with shortened infusion duration; Infusion related reaction (IRR)/hypersensitivity/anaphylactic reaction	Duration of study participation (up to 5 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)	Disease activity score in 28 joints (DAS28) will be calculated in two ways using the following two equations: DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln(ESR)) + (0.014 × GH); DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln(CRP + 1)) + (0.014 × GH) + 0.96 Where: TJC28 = number of tender joints (0-28): tender joint count (TJC); SJC28 = number of swollen joints (0-28): swollen joint count (SJC); ESR = ESR measurement (mm/h); CRP = CRP measurement (mg/L); GH = Patient Global Assessment of Disease Activity measured on VAS (0 - 100 mm) Disease activity is indexed as follows, on a 10 point scale, with higher numbers indicating worse disease activity: Remission: DAS28 < 2.6 Low Disease Activity: 2.6 ≤ DAS28 < 3.2 Moderate Disease Activity: 3.2 ≤ DAS28 ≤ 5.1 High Disease Activity: 5.1 < DAS28	Day 0 ~ Week 198 (every 6 months ±6 weeks)
Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability	The arthritis-related functional disability will be measured using the disability index of the Health Assessment Questionnaire (HAQ), a validated, self-administered form that assesses functional ability in a number of relevant areas, including the ability to dress, rise from bed, eat, walk, maintain personal hygiene, reach, grip and other activities on a scale ranging from 0 (without any difficulty) to 3 (unable to do). Scores range from 0 to 3, with higher scores indicating worse disability. There are 8 categories within the Health Assessment Questionnaire. The answer to each question will be scored as follows: Without any difficulty = 0, With some difficulty = 1, With much difficulty = 2, Unable to do = 3. Divide the summed category scores (using the adjustment score) by the number of categories answered to obtain the HAQ estimate of physical ability.	Day 0 ~ Week 198 (every 6 months ±6 weeks)

Collaborators and Investigators

• Sponsor: Celltrion
• Investigators: Principal Investigator: Klara Sirova, Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic

Publications and helpful links

General Publications

• Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2013
• Primary Completion (Actual): March 2, 2020
• Study Completion (Actual): March 2, 2020

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (Estimated): September 23, 2015

Study Record Updates

• Last Update Posted (Actual): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: CT-P13 4.2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No