Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

NCT01197534 | Completed Phase 3 Results DMC

• 2 other identifiers: D4300C000022010-020744-35
• Study Type: interventional
• Target: 913
• Locations: 16 countries
• Sites: 149

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 disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients With 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 CRP) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.

  24 weeks

Secondary Outcomes (11)

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

  1 week

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

  24 weeks

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

  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 12, Comparison Between Fostamatinib and Placebo

  12 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, fostamatinib

Interventions

fostamatinib DRUG

fostamatinib 100 mg twice daily

Dosing Regimen A

placebo, fostamatinib DRUG

Placebo for 24 weeks followed by fostamatinib 100 mg 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
• Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine
• or more swollen joints and 4 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 12 months 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 a TNF alpha antagonist, anakinra or previous treatment with other biological agent
• Severe renal impairment
• Neutropenia

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (149)

Research Site

Birmingham, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Huntington Beach, California, United States

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Torrance, California, United States

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Trumbull, Connecticut, United States

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

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Boca Raton, Florida, United States

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Brandon, Florida, United States

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Jacksonville, Florida, United States

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Miami, 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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Canton, Georgia, United States

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Decatur, Georgia, United States

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Macon, Georgia, United States

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Boise, Idaho, United States

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South Bend, Indiana, United States

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Elizabethtown, Kentucky, United States

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Crofton, Maryland, United States

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Cumberland, Maryland, United States

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Hagerstown, Maryland, United States

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Kalamazoo, Michigan, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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Kalispell, Montana, United States

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Omaha, Nebraska, United States

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Manalapan, New Jersey, United States

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Las Cruces, New Mexico, United States

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Brooklyn, 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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Syracuse, 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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Dayton, Ohio, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Greenville, South Carolina, United States

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Orangeburg, South Carolina, United States

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Memphis, 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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Lubbock, Texas, United States

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Mesquite, Texas, United States

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San Antonio, Texas, United States

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Chesapeake, Virginia, United States

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Tacoma, Washington, United States

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Edmonton, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Bowmanville, Ontario, Canada

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Hamilton, Ontario, Canada

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Mississauga, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Reading, Canada

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Brno, Czechia

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Bruntál, Czechia

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Česká Lípa, Czechia

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České Budějovice, Czechia

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Hlučín, Czechia

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Liberec, Czechia

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Ostrava - Trebovice, Czechia

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Prague, Czechia

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Sokolov, Czechia

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Terezín, Czechia

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Zlín, Czechia

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Erlangen, Germany

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Hamburg, Germany

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München, Germany

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Hyderabad, Andhra Pradesh, India

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Ahmedabad, Gujarat, India

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Gandhinagar, Gujarat, India

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Vadodara, Gujarat, India

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Bangalore, Karnataka, India

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Mangalore, Karnataka, India

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Mumbai, Maharashtra, India

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Pune, Maharashtra, India

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Coimbatore, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Lucknow, India

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Ashkelon, Israel

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Beer Yaakov, Israel

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Haifa, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Ramat Gan, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Iesi, AN, Italy

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Legnano, MI, Italy

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Udine, UD, Italy

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Varese, VA, Italy

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Liepāja, Latvia

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Riga, Latvia

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Valmiera, Latvia

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Kaunas, Lithuania

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Klaipėda, Lithuania

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Šiauliai, Lithuania

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Aveiro, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Baia Mare, Romania

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Brailari, Romania

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Bucharest, Romania

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Ploieşti, Romania

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Belgrade, Serbia

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Kragujevac, Serbia

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Niška Banja, Serbia

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Novi Sad, Serbia

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Kempron Park, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Durban, Kz-natal, South Africa

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Cape Town, W Cape, South Africa

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Port Elizabeth, South Africa

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Stellenbosch, South Africa

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La Laguna (tenerife), Canary Islands, Spain

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Mérida, Extremadura, Spain

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Barcelona, Spain

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Getafe, Spain

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Lutsk, Ukraine

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Lviv, Ukraine

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Simferopol, Ukraine

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Vinnytsia, Ukraine

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Zaporizhzhya, Ukraine

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Zaporyzhzhya, Ukraine

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Maidstone, Kent, United Kingdom

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Eastbourne, Sussex, United Kingdom

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Solihull, West Midlands, United Kingdom

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Basingstoke, United Kingdom

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Cambridge, United Kingdom

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London, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Stoke-on-Trent, United Kingdom

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Swindon, United Kingdom

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Related Links

• Related Info
• 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
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 17, 2014
• Results First Posted: April 17, 2014

Record last verified: 2014-03

Locations

IT (4); IL (8); DE (3); US (57); CA (11); ZA (6); LA (3); GB (9); SE (4); ES (4); RO (4); PT (3); IN (11); LI (3); CZ (11); UA (8)