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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: ASK8007; Drug: Placebo

• Registration Number: NCT00411424
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-14
• Study Start: 2007-09
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ASK8007	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability MD ASK8007	up to 10 weeks after last dose

Secondary Outcome Measures

Name	Time	Method
DAS28+CD68	Day 43 compared to baseline