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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993317
• Other study ID #: 101-KOA-0801i
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2009
• Last updated: September 25, 2012
• Start date: October 2009
• Est. completion date: August 2011

Study information

• Verified date: September 2012
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Placebo of CDP870
Given every 2 weeks until Week22 (SC)
• CDP870 200mg
400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC)
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Catholic University Hospital of Daegu	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Eulji University Hospital	Daejeon
Korea, Republic of	Inha University Hospital	Inchon
Korea, Republic of	Chonnam National University Hospital	Kwangju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University of Korea ST.Mary's Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang Universoty Hospital	Seoul
Korea, Republic of	KonKuk University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul national univeristy	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 Responses at 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.	Week 24	No
Secondary	ACR 20 Responses at 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.	Week 12	No
Secondary	ACR50 Responses at 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.	Week 12	No
Secondary	ACR70 Responses at Week 12	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.	Week12	No
Secondary	ACR50 Responses at Week 24		Week 24	No
Secondary	ACR70 Responses at Week24		Week 24	No
Secondary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)	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.	Baseline and Week 24	No