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OpenTrials
Completed

NCT Number: NCT01197066

Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis

This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24
  • Have a clear chest X-ray at the Entry visit
  • Negative urine pregnancy test at the Entry
  • Continue treatment on methotrexate

Exclusion criteria

  • Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
  • Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
  • At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i
  • NYHA (New York Heart Association) Class III or IV congestive heart failure
  • Current or history of tuberculosis
  • History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
  • History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease
  • High risk of infection
  • Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug

Treatment and study plan

Certolizumab pegol

Drug

Certolizumab Pegol 200mg

Other names: CDP870, CIMZIA, Perstymab

Primary outcomes

  1. To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters.

    Time frame: Up to 7 years

    Treatment will continue until the drug is commercially available in the country.

Secondary outcomes

  1. To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.

    Time frame: Up to 7 years

    Treatment will continue until the drug is commercially available in the country.

  2. Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36)

    Time frame: Up to 7 years

    Treatment will continue until the drug is commercially available in the country.

  3. To assess the achievement of clinical remission measured by DAS28.

    Time frame: Up to 7 years

    Treatment will continue until the drug is commercially available in the country.

  4. The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).

    Time frame: Up to 7 years

    Treatment will continue until the drug is commercially available in the country.

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase Ⅲ Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Sep 9, 2010
Registry last updated
Jun 10, 2022

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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