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

NCT02557308 | Terminated Results

• 1 other identifier: CT-P13 4.4
• Study Type: observational
• Target: 329
• Locations: 0 countries
• Sites: N/A

Brief Summary

An Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Ankylosing Spondylitis

Conditions

Ankylosing Spondylitis

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 related reaction (IRR)/hypersensitivity/anaphylactic reaction

  Duration of study participation (up to 5 years)

Secondary Outcomes (5)

• The Number and Percentage of Patients Achieving BASDAI 50

  Month 6 ~ Month 48 (every 6 months ± 6 weeks)

• Descriptive Statistics for BASFI

  Day 0 ~ Month 48 (every 6 months ± 6 weeks)

• Descriptive Statistics of Physician Global Assessment Score

  Day 0 ~ Month 48 (every 6 months ±6 weeks)

• Descriptive Statistics of Patient Global Assessment Score

  Day 0 ~ Month 48 (every 6 months ±6 weeks)

• Descriptive Statistics of Spinal Pain Score

  Day 0 ~ Month 48 (every 6 months ±6 weeks)

Study Arms (8)

Remsima™

Patients who have received only 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 switched from Remsima to Remicade 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 were included in this analysis group.

Other anti-TNF drugs

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 biologic treatment other than anti-TNF before study enrollment 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 were 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

Approximately 1000 male or female patients with confirmed diagnosis of AS.

You may qualify if:

• Adult patients
• Patients with active AS
• Patients who meet the following conditions can be enrolled:
• i) The RemsimaTM cohort will include all patients who will start RemsimaTM at the time of enrolment in accordance to the approved product label ii) Patients who have started to be treated with an established anti -TNF such as Infliximab (Remicade®), Etanercept, Adalimumab and etc. within 6 months
• Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of RemsimaTM.
• Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records

You may not qualify if:

• Patients with a history of hypersensitivity to infliximab
• Patients with a current or past history of chronic infection
• Current diagnosis of TB or severe or chronic infections (e.g. sepsis, abscess or opportunistic infections or invasive fungal infections), or a past diagnosis of TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
• Recent exposure to persons with active TB, or a positive test result for latent TB (defined as a positive interferon-γ release assay \[IGRA\] with a negative examination of chest X-ray) at Screening.
• 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

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

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: May 15, 2015
• First Posted: September 23, 2015
• Study Start: May 26, 2015
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10