Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00411424
• Date of registration: 12/12/2006
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Inc
• Public title: Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis
• Scientific title: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Initial Efficacy of ASK8007 in Comparison With Placebo in Patients With Active Rheumatoid Arthritis - a Randomized, Double Blind, Placebo-controlled, Combined Single Dose Escalation and Multiple Dose Study
• Date of first enrolment: September 2007
• Target sample size: 54
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00411424
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium, France, Hungary, Ireland, Netherlands, Spain, United Kingdom

Contacts

• Name: Use Central Contact
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

Inclusion Criteria:

- meet the American Rheumatism Association (ARA) 1987 revised criteria for the
classification of RA (also referred to as the American College of Rheumatology [ACR]
criteria);

- being treated with an adequate dose (to the discretion of the local physicians) of
either MTX or leflunomide (LEF)or sulfasalazine (SS2) for at least 4 months prior to
baseline of which the last 6 weeks before baseline were at a stable dose;

- have active poly-arthritis (i.e. active rheumatoid arthritis as defined in detail in
the protocol)

Exclusion Criteria:

- have been treated with any registered or non-registered investigational drug in the
context of a clinical intervention study during the last 3 months before baseline;

- have been treated with TNFa-blockers within a certain period of time (defined for
each medication) before baseline;

- have been treated with any DMARD other than MTX, LEF or SS2 during the last month
before baseline;

- documented evidence for the presence of clinically severe, unstable, or
uncontrollable renal, hepatic, respiratory, hematological, genitourinary,
cardiovascular, endocrine, neurological, psychiatric, or other medical illness which
would, in the opinion of the investigator, put the patient at safety risk or mask
measures of efficacy.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: ASK8007

Drug: Placebo

Primary Outcome(s)

Safety and tolerability MD ASK8007 [Time Frame: up to 10 weeks after last dose]

Secondary Outcome(s)

DAS28+CD68 [Time Frame: Day 43 compared to baseline]

Secondary ID(s)

EudraCT number: 2006-000172-33

8007-CL-0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors