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

March 19, 2013 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
IV
EXPERIMENTAL: 1
Drug: ASK8007
IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability MD ASK8007
Time Frame: up to 10 weeks after last dose
up to 10 weeks after last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
DAS28+CD68
Time Frame: Day 43 compared to baseline
Day 43 compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

December 12, 2006

First Submitted That Met QC Criteria

December 12, 2006

First Posted (ESTIMATE)

December 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8007-CL-0001
  • EudraCT number: 2006-000172-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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