NCT00411424

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Sep 2007

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
6 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 21, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

December 12, 2006

Last Update Submit

March 19, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisRandomized Control TrialTreatment outcomesMonoclonal antibody

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability MD ASK8007

    up to 10 weeks after last dose

Secondary Outcomes (1)

  • DAS28+CD68

    Day 43 compared to baseline

Study Arms (2)

1

EXPERIMENTAL
Drug: ASK8007

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ASK8007DRUG

IV

1
PlaceboDRUG

IV

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Budapest, 1027, Hungary

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

A Coruña, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Santiago, Spain

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Newcastle, United Kingdom

Location

Related 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.

    PMID: 21917822BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ASK8007 monoclonal antibody

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Use Central Contact

    Astellas Pharma Europe B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 14, 2006

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 21, 2013

Record last verified: 2013-03

Locations

HU(1)BE(1)GB(2)ES(3)IE(1)NL(2)