Trial Outcomes & Findings for A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis (NCT NCT01640054)

Results Overview

AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

115 participants

Primary outcome timeframe

Entry in extension to study termination (variable duration; maximum 52 weeks)

Results posted on

2014-03-28

Participant Flow

A total of 115 patients were enrolled; all received at least 1 dose of investigational product. This was an open-label study.

No patients failed screening.

Participant milestones

Participant milestones
Measure	FOSTA 100 MG QD PO Fostamatinib 100 mg qd
Overall Study STARTED	115
Overall Study Did Not Receive Treatment	0
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	FOSTA 100 MG QD PO Fostamatinib 100 mg qd
Overall Study Study-specific disc criteria	1
Overall Study Lack of Efficacy	3
Overall Study Adverse Event	2

Baseline Characteristics

A Long Term Study to Assess the Safety of Fostamatinib in Patients in Asia With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOSTA 100 MG QD PO n=115 Participants Fostamatinib 100 mg qd
Age, Continuous	53 years STANDARD_DEVIATION 11.3 • n=99 Participants
Sex: Female, Male Female	101 Participants n=99 Participants
Sex: Female, Male Male	14 Participants n=99 Participants
Race/Ethnicity, Customized White	0 Participants n=99 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=99 Participants
Race/Ethnicity, Customized Asian	115 Participants n=99 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=99 Participants
Race/Ethnicity, Customized Indian or Pakistani	0 Participants n=99 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Entry in extension to study termination (variable duration; maximum 52 weeks)

Population: The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.

AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event

Outcome measures

Outcome measures
Measure	FOSTA 100 MG QD PO n=115 Participants Fostamatinib 100 mg qd
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category Any AE leading to discontinuation of IP	2.6 Percentage of patients
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category Any AE	62.6 Percentage of patients
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category Any AE with outcome of death	0 Percentage of patients
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category Any SAE (including events with outcome of death)	3.5 Percentage of patients

SECONDARY outcome

Timeframe: Every 12 weeks for one year then every 24 weeks until study end

Population: Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 12 weeks for one year then every 24 weeks until study end

Population: Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 12 weeks for one year then every 24 weeks until study end

Population: Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 12 weeks for one year then yearly until study end

Population: Insufficient data were available for analysis due to sparse data collection and the early termination of the study.

n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey

Outcome measures

Outcome data not reported

Adverse Events

FOSTA 100 MG QD PO

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FOSTA 100 MG QD PO n=115 participants at risk Fostamatinib 100 mg qd
Gastrointestinal disorders PANCREATITIS ACUTE	0.87% 1/115 • Number of events 1
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.87% 1/115 • Number of events 1
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.87% 1/115 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SEBORRHOEIC KERATOSIS	0.87% 1/115 • Number of events 1

Other adverse events

Other adverse events
Measure	FOSTA 100 MG QD PO n=115 participants at risk Fostamatinib 100 mg qd
Blood and lymphatic system disorders NEUTROPENIA	5.2% 6/115 • Number of events 7
Infections and infestations NASOPHARYNGITIS	12.2% 14/115 • Number of events 18
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	6.1% 7/115 • Number of events 8
Vascular disorders HYPERTENSION	6.1% 7/115 • Number of events 7

Additional Information

Dave Goldstraw

AstraZeneca Pharmaceuticals

Phone: +44 (0)1625 512415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60