Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist

NCT01197755 | Completed Phase 3 Results DMC

• 2 other identifiers: D4300C000032010-020745-27
• Study Type: interventional
• Target: 323
• Locations: 16 countries
• Sites: 135

Brief Summary

The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Achieving ACR20 at Week 24, 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 daily.

  24 weeks

Secondary Outcomes (11)

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

  1 week

• Proportion of Patients Achieving ACR50 at Week 24, Comparison Between Fostamatinib and Placebo

  24 weeks

• Proportion of Patients Achieving ACR70 at Week 24, Comparison Between Fostamatinib and Placebo

  24 weeks

• ACRn - Comparison Between Fostamatinib and Placebo at Week 24

  Baseline and 24 weeks

• Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo

  24 weeks

Study Arms (3)

Dosing Regimen A

EXPERIMENTAL

Oral Treatment

Drug: fostamatinib

Dosing Regimen B

EXPERIMENTAL

Oral Treatment

Drug: fostamatinib

Dosing Regimen C

PLACEBO COMPARATOR

Oral Treatment

Drug: placebo

Interventions

fostamatinib DRUG

fostamatinib 100 mg twice daily

Dosing Regimen A

placebo DRUG

Placebo twice daily

Dosing Regimen C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active rheumatoid arthritis (RA) diagnosed after the age of 16
• Currently taking methotrexate
• or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
• At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

You may not qualify if:

• Females who are pregnant or breast feeding
• Poorly controlled hypertension
• Liver disease or significant liver function test abnormalities
• Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
• Recent or significant cardiovascular disease
• Significant active or recent infection including tuberculosis
• Previous failure to respond to anakinra or previous treatment with biological agent (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
• Severe renal impairment
• Neutropenia

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (135)

Research Site

Anniston, Alabama, United States

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Huntsville, Alabama, United States

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Tuscaloosa, Alabama, United States

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Mesa, Arizona, United States

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Scottsdale, Arizona, United States

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Hot Springs, Arkansas, United States

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Glendale, California, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Palo Alto, California, United States

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Santa Maria, California, United States

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Torrance, California, United States

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Tustin, California, United States

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Upland, California, United States

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Colorado Springs, Colorado, United States

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Bridgeport, Connecticut, United States

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Trumbull, Connecticut, United States

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Lewes, Delaware, United States

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Brandon, Florida, United States

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Jacksonville, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Venice, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Canton, Georgia, United States

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Idaho Falls, Idaho, United States

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Decatur, Illinois, United States

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Cedar Rapids, Iowa, United States

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Bowling Green, Kentucky, United States

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Elizabethtown, Kentucky, United States

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Crofton, Maryland, United States

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Fall River, Massachusetts, United States

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Worcester, Massachusetts, United States

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Lansing, Michigan, United States

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Flowood, Mississippi, United States

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Florissant, Missouri, United States

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Richmond Heights, Missouri, United States

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Las Cruces, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Olean, New York, United States

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Rochester, New York, United States

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Roslyn, New York, United States

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Smithtown, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Greensboro, North Carolina, United States

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Dayton, Ohio, United States

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Mayfield Village, Ohio, United States

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Lake Oswego, Oregon, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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Hixson, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tacoma, Washington, United States

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Buenos Aires, Buenos Aires F.D., Argentina

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Córdoba, CRD, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, TUC, Argentina

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Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Quilmes, Argentina

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Rosario, Argentina

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San Juan, Argentina

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San Miguel de Tucumán, Argentina

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Brussels, Belgium, Belgium

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Ghent, Belgium, Belgium

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Liège, Belgium, Belgium

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Yvoir, Belgium

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Porto Alegre, Brasil, Brazil

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Goiânia, Goiás, Brazil

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Curitiba, Paraná, Brazil

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São Paulo, São Paulo, Brazil

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St. John's, Newfoundland and Labrador, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Rimouski, Quebec, Canada

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Bruntál, Czechia

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České Budějovice, Czechia

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Hlučín, Czechia

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Ostrava-trebovice, Czechia

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Prague, Czechia

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Zlín, Czechia

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Orléans, France

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Hamburg, Hamburg, Germany

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Aachen, North Rhine-Westphalia, Germany

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Leipzig, Saxony, Germany

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Erlangen, Germany

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Frankfurt, Germany

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Hamburg, Germany

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Heidelberg, Germany

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München, Germany

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Budapest, Hungary

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Ashkelon, Israel

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Haifa, Israel

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Kfar Saba, Israel

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Ramat Gan, Israel

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Tel Litwinsky, Israel

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Iesi, AN, Italy

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Ferrara, FE, Italy

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Chihuahua City, Chihuahua, Mexico

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Obrergon, Sonora, Mexico

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DF, Mexico

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Monterrey, Mexico

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Saltillo, Mexico

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Lisbon, Portugal

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Porto, Portugal

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Cape Town, South Africa

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Pretoria, South Africa

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Stellenbosch, South Africa

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Barcelona, Spain

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Reading, Berkshire, United Kingdom

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Warrington, Cheshire, United Kingdom

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Maidstone, Kent, United Kingdom

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Eastbourne, Sussex, United Kingdom

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Cambridge, United Kingdom

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Christchurch, United Kingdom

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Ipswich, United Kingdom

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London, United Kingdom

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Metropolitan Borough of Wirral, United Kingdom

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Nottingham, United Kingdom

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Westcliff-on-the Sea, United Kingdom

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Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune 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 PhD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 8, 2010
• First Posted: September 9, 2010
• Study Start: September 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-02

Locations

FR (1); DE (8); HU (1); ME (5); AR (10); CA (5); ZA (3); IT (2); BE (4); IL (5); BR (4); ES (1); GB (11); US (67); CZ (6); PT (2)