Clinical trial NCT00993317: A Study of CDP870 as Add-on Meditation to Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: CDP870
Korea
CIMZIA
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-10-12
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ACR20 Responses at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: ACR 20 Responses at Week 12
timeFrame: Week 12
measure: ACR50 Responses at Week 12
timeFrame: Week 12
measure: ACR70 Responses at Week 12
timeFrame: Week12
measure: ACR50 Responses at Week 24
timeFrame: Week 24
measure: ACR70 Responses at Week24
timeFrame: Week 24
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Catholic University Hospital of Daegu
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
city: Inchon
country: Korea, Republic of
facility: Inha University Hospital
city: Kwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea ST.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang Universoty Hospital
city: Seoul
country: Korea, Republic of
facility: KonKuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul national univeristy
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Severance Hospital
name: Soo-kon Lee, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: