NCT00993317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 27, 2012

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

1.8 years

First QC Date

October 9, 2009

Results QC Date

May 22, 2012

Last Update Submit

September 25, 2012

Conditions

Rheumatoid Arthritis

Keywords

CDP870KoreaCIMZIA

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • ACR 20 Responses at Week 12

    Week 12

  • ACR50 Responses at Week 12

    Week 12

  • ACR70 Responses at Week 12

    Week12

  • ACR50 Responses at Week 24

    Week 24

  • ACR70 Responses at Week24

    Week 24

  • +1 more secondary outcomes

Study Arms (2)

Placebo of CDP870+MTX

PLACEBO COMPARATOR
Drug: Placebo of CDP870Drug: Methotrexate

CDP870 200mg+MTX

EXPERIMENTAL
Drug: CDP870 200mgDrug: Methotrexate

Interventions

Placebo of CDP870DRUG

Given every 2 weeks until Week22 (SC)

Placebo of CDP870+MTX
CDP870 200mgDRUG

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

Also known as: CIMZIA
CDP870 200mg+MTX
MethotrexateDRUG

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+MTXPlacebo of CDP870+MTX

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Catholic University Hospital of Daegu

Daegu, South Korea

Location

Eulji University Hospital

Daejeon, 302-799, South Korea

Location

Inha University Hospital

Inchon, South Korea

Location

Chonnam National University Hospital

Kwangju, South Korea

Location

Pusan National University Hospital

Pusan, South Korea

Location

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Catholic University of Korea ST.Mary's Hospital

Seoul, 150-713, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Hanyang Universoty Hospital

Seoul, South Korea

Location

KonKuk University Medical Center

Seoul, South Korea

Location

Seoul national univeristy

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab PegolMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Eun Young Cho, Clinical Trial Manager
Organization
Korea Otsuka Pharmaceutical
hyerim@otsuka.co.kr
+82-2-3287-9233

Study Officials

  • Soo-kon Lee, MD. PhD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 12, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 27, 2012

Results First Posted

September 27, 2012

Record last verified: 2012-09

Locations

KR(15)