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

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Placebo of CDP870 Drug: CDP870 200mg Drug: Methotrexate	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methotrexate sodium Certolizumab pegol

U.S. FDA Resources

Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:

ACR20 Responses at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
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 Outcome Measures:

ACR 20 Responses at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
ACR50 Responses at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
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.
ACR70 Responses at Week 12 [ Time Frame: Week12 ] [ Designated as safety issue: No ]
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.
ACR50 Responses at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
ACR70 Responses at Week24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
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.

Enrollment:	127
Study Start Date:	October 2009
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo of CDP870+MTX	Drug: Placebo of CDP870 Given every 2 weeks until Week22 (SC) 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.
Experimental: CDP870 200mg+MTX	Drug: CDP870 200mg 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week 22(SC) Other Name: CIMZIA 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.

Arms

Assigned Interventions

Placebo Comparator: Placebo of CDP870+MTX

Drug: Placebo of CDP870

Given every 2 weeks until Week22 (SC)

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.

Experimental: CDP870 200mg+MTX

Drug: CDP870 200mg

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

Other Name: CIMZIA

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993317

Locations

Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Catholic University Hospital of Daegu
Daegu, Korea, Republic of
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Inha University Hospital
Inchon, Korea, Republic of
Chonnam National University Hospital
Kwangju, Korea, Republic of
Pusan National University Hospital
Pusan, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Hanyang Universoty Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Seoul national univeristy
Seoul, Korea, Republic of
Catholic University of Korea ST.Mary's Hospital
Seoul, Korea, Republic of, 150-713
Gangnam Severance Hospital
Seoul, Korea, Republic of
KonKuk University Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of

Sponsors and Collaborators

Korea Otsuka Pharmaceutical Co.,Ltd.

Investigators

Principal Investigator:

Soo-kon Lee, MD. PhD

Yonsei University Severance Hospital

More Information

No publications provided

Responsible Party:	Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00993317 History of Changes
Other Study ID Numbers:	101-KOA-0801i
Study First Received:	October 9, 2009
Results First Received:	May 22, 2012
Last Updated:	September 25, 2012
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

CDP870
Korea
CIMZIA

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013