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

NCT ID: NCT00993317

Last Updated: 2012-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-08-31

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

CDP870; Korea; CIMZIA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo of CDP870+MTX

Group Type: PLACEBO_COMPARATOR

Placebo of CDP870

Intervention Type: DRUG

Given every 2 weeks until Week22 (SC)

Methotrexate

Intervention Type: 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.

CDP870 200mg+MTX

Group Type: EXPERIMENTAL

CDP870 200mg

Intervention Type: DRUG

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

Methotrexate

Intervention Type: 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.

Interventions

Placebo of CDP870

Given every 2 weeks until Week22 (SC)

Intervention Type: DRUG

CDP870 200mg

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

Intervention Type: DRUG

Methotrexate

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.

Intervention Type: DRUG

Other Intervention Names

CIMZIA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soo-kon Lee, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Kyungpook National University Hospital

Daegu, , South Korea

Catholic University Hospital of Daegu

Daegu, , South Korea

Eulji University Hospital

Daejeon, , South Korea

Inha University Hospital

Inchon, , South Korea

Chonnam National University Hospital

Kwangju, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Yonsei University Severance Hospital

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Catholic University of Korea ST.Mary's Hospital

Seoul, , South Korea

Gangnam Severance Hospital

Seoul, , South Korea

Hanyang Universoty Hospital

Seoul, , South Korea

KonKuk University Medical Center

Seoul, , South Korea

Seoul national univeristy

Seoul, , South Korea

Ajou University Hospital

Suwon, , South Korea

Countries

South Korea

Other Identifiers

101-KOA-0801i

Identifier Type: -

Identifier Source: org_study_id