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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00411424
Recruitment Status : Completed
First Posted : December 14, 2006
Last Update Posted : March 21, 2013
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ASK8007 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: ASK8007
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. Safety and tolerability MD ASK8007 [ Time Frame: up to 10 weeks after last dose ]

Secondary Outcome Measures :
  1. DAS28+CD68 [ Time Frame: Day 43 compared to baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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.

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00411424     History of Changes
Other Study ID Numbers: 8007-CL-0001
EudraCT number: 2006-000172-33
First Posted: December 14, 2006    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: March 2013

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