Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)

NCT01220518 | Completed Phase 1 DMC

• 1 other identifier: CT-P13 1.1
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• PK equivalence to remicade

  PK sampling at week 22

Secondary Outcomes (7)

• Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria

  at week 14, 30 and 54

• Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria

  at week 14, 30 and 54

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline

  at week 14, 30 and 54

• Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline

  at week 14, 30 and 54

• Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline

  at weeks 14, 30 and 54

Study Arms (2)

CT-P13

ACTIVE COMPARATOR

infliximab

Drug: Infliximab

Remicade

ACTIVE COMPARATOR

infliximab

Drug: Infliximab

Interventions

Infliximab DRUG

Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

CT-P13; Remicade

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with active ankylosing spondylitis
• BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4

You may not qualify if:

• have total ankylosing of spine
• have allergies to infliximab
• serious infection

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Inha University Hostpital

Incheon, South Korea

Location

Related Publications (2)

• Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9.

  PMID: 32905628 DERIVED

• Park W, Yoo DH, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, Sariego IG, Abud-Mendoza C, Escalante WJ, Kang SW, Andersone D, Blanco F, Hong SS, Lee SH, Braun J. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016 Jan 20;18:25. doi: 10.1186/s13075-016-0930-4.

  PMID: 26795209 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Infliximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Won Park, M.D., Ph.D.

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 14, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: June 1, 2012
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

KR (1)