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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00411424
First received: December 12, 2006
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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
IV
Placebo Comparator: 2 Drug: Placebo
IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 ClinicalTrials.gov identifier: NCT00411424

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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov 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
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 28, 2014