Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

NCT00791999 | Completed Phase 2 Results

• 2 other identifiers: CDP870-275-08-001JapicCTI-080665
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 8

Brief Summary

The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

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 (4)

CDP870 100mg

EXPERIMENTAL

200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks

Drug: CDP870 100mg

CDP870 200mg

EXPERIMENTAL

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

Drug: CDP870 200mg

CDP870 400mg

EXPERIMENTAL

400mg CDP870 given every 2 weeks

Drug: CDP870 400mg

Placebo

PLACEBO COMPARATOR

Placebo given every 2 weeks

Drug: Placebo of CDP870

Interventions

CDP870 400mg DRUG

400mg CDP870 given every 2 weeks until Week22 (SC)

CDP870 400mg

CDP870 200mg DRUG

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

CDP870 200mg

CDP870 100mg DRUG

200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC)

CDP870 100mg

Placebo of CDP870 DRUG

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 9 tender joints and 9 swollen joints
• ESR of 30 mm/hour or CRP of 1.5 mg/dL
• Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.

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 (8)

Unknown Facility

Chubu 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

Unknown Facility

Tohoku Region, Japan

Location

Related Publications (1)

• Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Shoji T, Sakamaki Y, van der Heijde D, Miyasaka N, Koike T. Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Mod Rheumatol. 2014 Sep;24(5):715-24. doi: 10.3109/14397595.2013.864224. Epub 2013 Dec 9.

  PMID: 24313916 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: Medical Advisor of the Clinical Trial

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 2
• 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, 2011
• Last Updated: August 10, 2012
• Results First Posted: August 6, 2012

Record last verified: 2012-08

Locations

JP (8)