Efficacy Confirmation Trial of CDP870 Without Coadministration of Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

NCT00791921 | Completed Phase 3 Results

• 1 other identifier: CDP870-275-08-003
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 7

Brief Summary

The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Certolizumab Pegol; Cimzia

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology 20% (ACR20) Response at Week 12

  ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1)Health Assessment Questionnaire-Disability Index (HAQ-DI), 2)C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS)

  Baseline, Week 12

Secondary Outcomes (1)

• American College of Rheumatology 20% (ACR20) Response at Week 24

  Baseline, Week 24

Study Arms (2)

CDP870 200mg

EXPERIMENTAL

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks

Drug: CDP870

Placebo

PLACEBO COMPARATOR

Placebo of CDP870

Drug: Placebo of CDP870

Interventions

CDP870 DRUG

400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks until Week22 subcutaneously(SC)

CDP870 200mg

Placebo of CDP870 DRUG

Placebo given every 2 weeks until Week22 (SC)

Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have a diagnosis of 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.
• Subjects must have active RA disease as defined by:
• At least 6 tender joints and 6 swollen joints
• ESR of 28 mm/hour or CRP of 2.0 mg/dL
• Subjects who have failed to respond or have been resistant to at least one DMARD (including MTX)
• Subjects in whom MTX cannot be administered for any of the reasons(incomplete response/safety concerns)

You may not qualify if:

• Patients who have a diagnosis of any other inflammatory arthritis
• Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
• Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
• Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
• Patients who currently have, or who have a history of, tuberculosis
• Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
• Patients who currently have, or who have a history of, malignancy
• Female patients who are breastfeeding or pregnant, who are of childbearing potential
• Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead
• UCB Japan Co. Ltd.: collaborator

Study Sites (7)

Unknown Facility

Chube Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushuh Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Related Publications (1)

• Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Iwai K, Sakamaki Y, van der Heijde D, Miyasaka N, Koike T. Efficacy and safety of certolizumab pegol without methotrexate co-administration in Japanese patients with active rheumatoid arthritis: the HIKARI randomized, placebo-controlled trial. Mod Rheumatol. 2014 Jul;24(4):552-60. doi: 10.3109/14397595.2013.843764. Epub 2013 Nov 1.

  PMID: 24981319 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Kazuhiko Yamamoto, Medical Advisor of the Clinical Trial
• Organization: Professor, Department of Allergy and Rheumatology, Division of Internal Medicine, Graduate School of Medicine, University of Tokyo

yamamoto-tky@umin.ac.jp

+81 3 5800 8825

Study Officials

• Katsuhisa Saito

  OPCJ

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 17, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 7, 2012
• Results First Posted: August 6, 2012

Record last verified: 2012-08

Locations

JP (7)