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

NCT02557295 | Terminated Results

• 1 other identifier: CT-P13 4.2
• Study Type: observational
• Target: 248
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Descriptive Statistics of Disease Activity Score in 28 Joints (DAS28) (ESR) and DAS28 (CRP)

  Day 0 ~ Week 198 (every 6 months ±6 weeks)

• Descriptive Statistics for Actual Value of Health Assessment Questionnaire (HAQ) Estimate of Physical Ability

  Day 0 ~ Week 198 (every 6 months ±6 weeks)

Study Arms (9)

Remsima™

Patients who have received only Remsima or switched from non-biologic treatment to Remsima were included in this analysis group.

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.

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 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Celltrion: lead

Related Publications (1)

• 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.

  PMID: 34250583 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: JiWoong Lim
• Organization: Celltrion Inc

jiwoong.lim@celltrion.com

82-32-850-5702

Study Officials

• Klara Sirova

  Revmatologie MUDr. Klara Sirova s.r.o. Chelčického 616/12 , 702 00, Czech Republic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: September 23, 2015
• Study Start: December 17, 2013
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: November 26, 2024
• Results First Posted: February 5, 2024

Record last verified: 2024-10