Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

American College of Rheumatology 20 (ACR20) Response at 6 Months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months
6 months

Secondary Outcomes (80)

American College of Rheumatology 20 (ACR20) Response at 1 Week
1 week
American College of Rheumatology 20 (ACR20) Response at 2 Weeks
2 weeks
American College of Rheumatology 20 (ACR20) Response at 1 Month
1 month
American College of Rheumatology 20 (ACR20) Response at 6 Weeks
6 weeks
American College of Rheumatology 20 (ACR20) Response at 2 Months
2 months
+75 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

R788, 100 mg tablet, orally, twice-a-day

Drug: Fostamatinib disodium (R935788)

2

EXPERIMENTAL

R788, 150 mg tablet, orally, once a day

Drug: Fostamatinib disodium (R935788)

3

PLACEBO COMPARATOR

Placebo, orally, either once a day, or twice a day

Drug: Placebo

Interventions

Fostamatinib disodium (R935788)Drug

100 mg tablet, orally, twice-a-day

Also known as: R935788

Fostamatinib disodium (R935788)Drug

150 mg tablet, orally, once a day

Also known as: R935788

Eligibility Criteria

Age18 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/EC-approved Informed Consent Form (ICF) prior to admission to this study.
Males and females, 18 years of age or older, with active RA for at least 6 months prior to Day 1 dosing.

Sponsors & Collaborators

Rigel Pharmaceuticals
Industrylead

Study Sites (65)

Divison of Rheumatology Allergy and Immunology

La Jolla, California, 92037, United States

Desert Medical Advances

Palm Desert, California, 92260, United States

Arthritis & Osteoporosis Center, PC

Hamden, Connecticut, 06518, United States

Cynthia Morgan

Washington D.C., District of Columbia, 20003, United States

Florida Medical Research Institute

Gainsville, Florida, 32607, United States

Paddock Park Clinical Research

Ocala, Florida, 34474, United States

Jeffrey Poiley, MD

Orlando, Florida, 32804, United States

Related Publications (1)

Weinblatt ME, Kavanaugh A, Genovese MC, Musser TK, Grossbard EB, Magilavy DB. An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis. N Engl J Med. 2010 Sep 30;363(14):1303-12. doi: 10.1056/NEJMoa1000500. Epub 2010 Sep 22.
PMID: 20879879DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The 2 placebo groups (bid and qd) were pooled for all efficacy data summaries and analysis since the observed ACR20 response rate difference between the placebo groups was \<15 percentage points (prospectively defined in protocol).

Results Point of Contact

Title: Anne-Marie Duliege, MD
Organization: Rigel

Study Officials

Daniel B Magilavy, MD
Rigel Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

457 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
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

May 2008

Date type not reported

This date has not been verified as actual or estimated.

Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (80)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (65)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (80)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (65)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations