Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis

Keywords

Outcome Measures

Primary Outcomes (1)

Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)

Secondary Outcomes (2)

DAS28-CRP Score
3 years
HAQ-DI Score
3 years

Study Arms (4)

1

EXPERIMENTAL

R935788 50 mg tablet, orally, twice-a-day

Drug: Fostamatinib Disodium (R935788)

2

EXPERIMENTAL

R935788 100 mg tablet, orally, twice-a-day

Drug: Fostamatinib Disodium (R935788)

3

EXPERIMENTAL

R935788 100 mg tablet, orally, once-a-day

Drug: Fostamatinib Disodium (R935788)

Interventions

Fostamatinib Disodium (R935788)Drug

50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD

Also known as: R935788

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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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
Patients who are being treated in Study C-788-006X

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (76)

Research Site

La Jolla, California, United States

Research Site

Palm Desert, California, United States

Research Site

Palo Alto, California, United States

Research Site

San Diego, California, United States

Research Site

Santa Maria, California, United States

Research Site

Hamden, Connecticut, United States

Research Site

Washington D.C., District of Columbia, 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

Results Point of Contact

Title: Dave Goldstraw
Organization: AstraZeneca Pharmaceuticals

Study Officials

Chris O'Brien, MD, PhD
AstraZeneca
STUDY DIRECTOR

Publication Agreements

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

Enrollment

624 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 9, 2008

Study Start

August 2008

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (76)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations

Study Stopped

Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (76)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations