NCT01569074

Brief Summary

The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Apr 2012

Geographic Reach
6 countries

34 active sites

Status
terminated

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

March 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 7, 2014

Completed
Last Updated

April 7, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

March 30, 2012

Results QC Date

November 21, 2013

Last Update Submit

February 27, 2014

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo

    ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.

    12 weeks

Secondary Outcomes (9)

  • Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo

    1 week

  • Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo

    12 weeks

  • Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo

    12 weeks

  • ACRn - Comparison Between Fostamatinib and Placebo at Week 12

    Baseline and 12 weeks

  • Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo

    12 weeks

  • +4 more secondary outcomes

Study Arms (5)

Dosing A regimen

EXPERIMENTAL

Oral treatment

Drug: Fostamatinib

Dosing B regimen

EXPERIMENTAL

Oral treatment

Drug: Fostamatinib

Dosing C regimen

EXPERIMENTAL

Oral treatment

Drug: Fostamatinib

Dosign D regimen

EXPERIMENTAL

Oral treatment

Drug: Fostamatinib

Dosing E regimen

PLACEBO COMPARATOR

Oral treatment

Drug: Placebo

Interventions

FostamatinibDRUG

Fostamatinib 100mg twice daily for 12 weeks

Dosing A regimen
PlaceboDRUG

Placebo twice daily for 12 weeks

Dosing E regimen

Eligibility Criteria

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

You may qualify if:

  • Male or female aged 18 and over
  • Active rheumatoid arthritis (RA) diagnosed after the age of 16
  • or more swollen joints and 6 or more tender/painful joints from certain joints in the hands, wrists, arms and knees
  • At least one of: positive result for rheumatoid factor test, either in the past or currently (blood test); x-ray showing bone erosion within the last 12 months; presence of certain antibodies in the blood (blood test)
  • Currently taking methotrexate for at least 4 months (and on a stable dose for at least 6 weeks)

You may not qualify if:

  • Females who are pregnant or breast feeding
  • Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders.
  • Previously taken, but not responded to, certain biological treatments for rheumatoid arthritis
  • High blood pressure that is not controlled by medication
  • Low levels of neutrophils in the blood (blood test).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Research Site

New Territories, HK, Hong Kong

Location

Research Site

Hong Kong, Hong Kong

Location

Research Site

Matsuyama, Ehime, Japan

Location

Research Site

Fukuoka, Fukuoka, Japan

Location

Research Site

Kitakyushu-shi, Fukuoka, Japan

Location

Research Site

Kurume, Fukuoka, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Kato-shi, Hyōgo, Japan

Location

Research Site

Kasama-shi, Ibaraki, Japan

Location

Research Site

Kumamoto, Kumamoto, Japan

Location

Research Site

Sendai, Miyagi, Japan

Location

Research Site

Isahaya, Nagasaki, Japan

Location

Research Site

Nagasaki, Nagasaki, Japan

Location

Research Site

Omura-shi, Nagasaki, Japan

Location

Research Site

Sasebo-shi, Nagasaki, Japan

Location

Research Site

Shibata, Niigata, Japan

Location

Research Site

Okayama, Okayama-ken, Japan

Location

Research Site

Tomigusuku-shi, Okinawa, Japan

Location

Research Site

Matsue, Shimane, Japan

Location

Research Site

Hamamatsu, Shizuoka, Japan

Location

Research Site

Shinjuku, Tokyo, Japan

Location

Research Site

tabashi City, Tokyo, Japan

Location

Research Site

Anyang-si, Gyeonggi-do, South Korea

Location

Research Site

Gwangju, South Korea

Location

Research Site

Incheon, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Chiayi City, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

Taichung, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Research Site

Bangkok, Thailand

Location

Research Site

Singapore, Thailand

Location

Research Site

Hanoi, Vietnam

Location

Research Site

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • Tanaka Y, Millson D, Iwata S, Nakayamada S. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study. Rheumatology (Oxford). 2021 Jun 18;60(6):2884-2895. doi: 10.1093/rheumatology/keaa732.

    PMID: 33254235DERIVED

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
dave.goldstraw@astrazeneca.com
+44 (0)1625 512415

Study Officials

  • Neil - Mackillop, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

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

March 30, 2012

First Posted

April 2, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 7, 2014

Results First Posted

April 7, 2014

Record last verified: 2014-02

Locations

VN(2)KR(4)JP(20)HK(2)TW(4)TH(2)