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Completed

NCT Number: NCT00993317

A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis

The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Catholic University Hospital of Daegu, Daegu, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria
  • Active RA disease as defined by at least 9 tender joints and 9 swollen joints, ESR of 30 mm/hour or CRP of 1.5 mg/dL
  • MTX (with or without folic acid) for at least 24 weeks prior to the Baseline visit, The dose of MTX and route of administration must have been stable for at least 8 weeks prior to the baseline visit. The minimum stable dose of MTX allowed is 10 mg weekly.

Exclusion criteria

  • Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)
  • Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
  • 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 (within 24 weeks , including herpes zoster), or any current sign or symptom that may indicate an infection (e.g., fever, cough)
  • High risk of infection
  • Have received any experimental non-biological therapy, within or outside a clinical trial in the 12 weeks prior to Baseline
  • Have received previous B-cell therapy (eg. Rituximab)
  • Have received any other biological therapy for RA within 24 weeks prior to Baseline visit, except for etanercept where a three month washout prior to baseline visit is acceptable
  • Have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
  • Failed to respond to previous treatment with an anti-TNF drug
  • 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

Placebo of CDP870

Drug

Given every 2 weeks until Week22 (SC)

CDP870 200mg

Drug

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC)

Other names: CIMZIA

methotrexate

Drug

Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit.

The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.

Primary outcomes

  1. ACR20 Responses at Week 24

    Time frame: Week 24

    Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.

Secondary outcomes

  1. ACR 20 Responses at Week 12

    Time frame: Week 12

    Achieving ACR20 means 20% or greater improvement in the number of tender joints, a 20% or more improvement in the number of swollen joints and a 20% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.

  2. ACR50 Responses at Week 12

    Time frame: Week 12

    Achieving ACR50 means 50% or greater improvement in the number of tender joints, a 50% or more improvement in the number of swollen joints and a 50% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.

  3. ACR70 Responses at Week 12

    Time frame: Week12

    Achieving ACR70 means 70% or greater improvement in the number of tender joints, a 70% or more improvement in the number of swollen joints and a 70% or greater improvement in at least three of the five remaining core set measures: Patient's and physician's global assessments, Patient's assessment of pain, disability index based on the Health Assessment Questionnaire and C-reactive Protein.

  4. ACR50 Responses at Week 24

    Time frame: Week 24

  5. ACR70 Responses at Week24

    Time frame: Week 24

  6. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

    Time frame: Baseline and Week 24

    Range of HAQ-DI score: 0-3 This outcome measures changes of HAQ-DI score at Week 24 from Baseline. Lower score of HAQ-DI represents a better outcome.

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 24-week Study to Assess the Efficacy and Safety of Certolizumab Pegol as Additional Medication to MTX in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 12, 2009
Registry last updated
Sep 27, 2012

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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