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OpenTrials
Completed

NCT Number: NCT01220518

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inha University Hostpital

Incheon, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Infliximab

Drug

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

Primary outcomes

  1. PK equivalence to remicade

    Time frame: PK sampling at week 22

Secondary outcomes

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

    Time frame: at week 14, 30 and 54

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

    Time frame: at week 14, 30 and 54

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

    Time frame: at week 14, 30 and 54

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

    Time frame: at week 14, 30 and 54

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

    Time frame: at weeks 14, 30 and 54

  6. Chest expansion at Weeks 14, 30 and 54 compared with Baseline

    Time frame: at weeks 14, 30 and 54

  7. Quality of life questionnaire (SF-36)

    Time frame: at week 14, 30 and 54

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

Randomized, Double-blind, Parallel-group, Phase 1 Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 14, 2010
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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