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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411424
• Other study ID #: 8007-CL-0001
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 12, 2006
• Last updated: March 19, 2013
• Start date: September 2007
• Est. completion date: June 2009

Study information

• Verified date: March 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyBelgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Ireland: Irish Medicines BoardNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Spain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ASK8007
IV
• Placebo
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

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

References & Publications (1)

Boumans MJ, Houbiers JG, Verschueren P, Ishikura H, Westhovens R, Brouwer E, Rojkovich B, Kelly S, den Adel M, Isaacs J, Jacobs H, Gomez-Reino J, Holtkamp GM, Hastings A, Gerlag DM, Tak PP. Safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of the monoclonal antibody ASK8007 blocking osteopontin in patients with rheumatoid arthritis: a randomised, placebo controlled, proof-of-concept study. Ann Rheum Dis. 2012 Feb;71(2):180-5. doi: 10.1136/annrheumdis-2011-200298. Epub 2011 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability MD ASK8007		up to 10 weeks after last dose	Yes
Secondary	DAS28+CD68		Day 43 compared to baseline	No

External Links

•   Link to results on JAPIC