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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00791999
• Date of registration: 14/11/2008
• Prospective Registration: No
• Primary sponsor: Otsuka Pharmaceutical Co., Ltd.
• Public title: Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
• Scientific title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Pharmacokinetics and Safety of CDP870 as add-on Medication to MTX in Japanese Active RA Patients Who Have an Incomplete Response to MTX.
• Date of first enrolment: November 2008
• Target sample size: 316
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00791999
• Study type: Interventional
• Phase: Phase 2/Phase 3

Countries of recruitment

Japan

Contacts

• Name: Katsuhisa Saito
• Affiliation: OPCJ

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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-TNFa drugs or who
previously failed to respond to treatment with 1 or more aint-TNFa drugs.



Age minimum: 20 Years
Age maximum: 74 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: CDP870 100mg

Drug: CDP870 400mg

Drug: Placebo of CDP870

Drug: CDP870 200mg

Primary Outcome(s)

American College of Rheumatology 20% (ACR20) Response at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

American College of Rheumatology 20% (ACR20) Response at Week 24 [Time Frame: Baseline, Week 24]

Secondary ID(s)

JapicCTI-080665

CDP870-275-08-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

UCB Japan Co. Ltd.

Results

• Results available: Yes
• Date Posted: 06/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00791999