Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis

Keywords

R935788Rheumatoid ArthritisSyk Kinase

Outcome Measures

Primary Outcomes (1)

The Primary Efficacy parameter is ACR20 response rate at 3 months post dosing.
12 weeks

Secondary Outcomes (12)

ACR 20/50 responses over time
12 weeks
Disease Activity Score (DAS) at baseline and endpoint
12 Weeks
Mean changes (SDs) from baseline in Swollen Joint Count (28 joint count)
12 Weeks
Mean changes (SDs) from baseline in Tender Joint Count (28 joint count)
12 Weeks
Mean changes (SDs) from baseline in Physician global assessment of disease activity by visual analog scale (VAS)
12 Weeks
+7 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

R788 50 mg PO bid

Drug: R788

2

EXPERIMENTAL

R788 100 mg PO bid

Drug: R788

3

EXPERIMENTAL

R788 150 mg PO bid

Drug: R788

Interventions

R788Drug

R788 50 mg, 100 mg, or 150 mg PO bid

Also known as: tamatinib fosdium

123

PlaceboDrug

Placebo PO bid

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must give written informed consent by signing an IRB-approved Informed Consent Form (ICF) prior to admission to this study.
Males and females, 18 to 75 years of age, with active RA for at least 12 months (functional class I-III, e.g., not bed or wheelchair-bound) who have been receiving weekly doses of methotrexate (10-25 mg/week) for a minimum of 180 days, and who have been receiving a stable MTX dose of at least 15 mg without any change in route or change in folic acid supplementation for at least 30 days.

Sponsors & Collaborators

Rigel Pharmaceuticals
Industrylead

Study Sites (38)

Pacific Arthritis Center Medical Group

Santa Maria, California, 93455, United States

DMI research

Ocala, Florida, 34471, United States

Renstar Medical Research

Ocala, Florida, 34471, United States

Arthritis & Osteoporosis Treatment Center

Orange Park, Florida, 32073, United States

Arthritis Associates Inc.

Orlando, Florida, 32804, United States

Arthritis Research of Florida, Inc.

Palm Harbor, Florida, 34684, United States

Arthritis Research of Florida

Palm Harbor, Florida, 34684, United States

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

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

Study Officials

Elliott Grossbard, M.D.
Rigel Pharmaceuticals
STUDY DIRECTOR
Michael Weinblatt, M.D.
Brigham and Women's Hospital
PRINCIPAL INVESTIGATOR
Arthur Kavanaugh, M.D.
University of California, San Diego
PRINCIPAL INVESTIGATOR

Enrollment

189 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 16, 2006

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (38)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (38)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations