Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: December 12, 2006
Last updated: March 19, 2013
Last verified: March 2013
The purpose of this study is to investigate the safety and tolerability of the new medication ASK8007, and to study whether it has a beneficial effect on joint inflammation in patients with rheumatoid arthritis.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: ASK8007
Drug: Placebo
Phase 1
Phase 2

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
Official 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety and tolerability MD ASK8007 [ Time Frame: up to 10 weeks after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • DAS28+CD68 [ Time Frame: Day 43 compared to baseline ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ASK8007
Placebo Comparator: 2 Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 TNFα-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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00411424

Leuven, Belgium, 3000
Budapest, Hungary, 1027
Dublin, Ireland
Amsterdam, Netherlands
Groningen, Netherlands
Barcelona, Spain
Coruna, Spain
Santiago, Spain
United Kingdom
London, United Kingdom
New Castle, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00411424     History of Changes
Other Study ID Numbers: 8007-CL-0001  EudraCT number: 2006-000172-33 
Study First Received: December 12, 2006
Last Updated: March 19, 2013
Health Authority: Hungary: National Institute of Pharmacy
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis
Randomized Control Trial
Treatment outcomes
Monoclonal antibody

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on January 17, 2017