Clinical trial NCT00411424: Safety, Tolerability and Efficacy Study of the New Medication ASK8007 to Treat Patients With Rheumatoid Arthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Randomized Control Trial
Treatment outcomes
Monoclonal antibody
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-12-14
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety and tolerability MD ASK8007
timeFrame: up to 10 weeks after last dose
Secondary outcomes:
measure: DAS28+CD68
timeFrame: Day 43 compared to baseline
Other outcomes:
Locations:
city: Leuven
country: Belgium
city: Budapest
country: Hungary
city: Dublin
country: Ireland
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Barcelona
country: Spain
city: Coruna
country: Spain
city: Santiago
country: Spain
city: London
country: United Kingdom
city: New Castle
country: United Kingdom
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.