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

NCT00805467 | Terminated Phase 2 Results DMC

• 2 other identifiers: C-935788-012D4300C00021
• Study Type: interventional
• Target: 624
• Locations: 11 countries
• Sites: 76

Brief Summary

The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.

Conditions

Rheumatoid Arthritis

Keywords

RA

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)

4

EXPERIMENTAL

R935788 150 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

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
• Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy
• Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative pregnancy test at the time of entry and at each laboratory determination.

You may not qualify if:

• The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
• unresolved Grade 2 or greater toxicity in a RA protocol studying R788
• uncontrolled or poorly controlled hypertension;
• recent (within past 2 months) serious surgery or infectious disease;
• recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
• known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;
• interstitial pneumonitis or active pulmonary infection;
• known laboratory abnormalities: ALT \> 1.2 x ULN, creatinine \>1.5x ULN, an ANC \<2,500/mm3 or 2.5 x 109/L, lymphocyte count \< 600/mm3 or 0.6 x 109L, Hgb \< 9 g/dL or 5 mmol/L, platelet count \<125,000/mm3 or 125 x 109/L are excluded.
• The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL.
• The patient is unable to report for clinical and laboratory monitoring as per protocol.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (76)

Research Site

La Jolla, California, United States

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Palm Desert, California, United States

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Palo Alto, California, United States

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San Diego, California, United States

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Santa Maria, California, United States

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Hamden, Connecticut, United States

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

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Aventura, Florida, United States

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Boca Raton, Florida, United States

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Gainesville, Florida, United States

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Ocala, Florida, United States

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Orange Park, Florida, United States

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Orlando, Florida, United States

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South Miami, Florida, United States

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Venice, Florida, United States

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Boise, Idaho, United States

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Coeur d'Alene, Idaho, United States

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South Bend, Indiana, United States

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Elizabethtown, Kentucky, United States

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Cumberland, Maryland, United States

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Hagerstown, Maryland, United States

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Lansing, Michigan, United States

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Omaha, Nebraska, United States

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Roslyn, New York, United States

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Smithtown, New York, United States

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Raleigh, North Carolina, United States

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Mayfiled Village, Ohio, United States

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Erie, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Jackson, Tennessee, United States

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Austin, Texas, United States

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San Antonio, Texas, United States

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Oklahoma City, Washington, United States

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Spokane, Washington, United States

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Antwerp, Belgium

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Ghent, Belgium

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Liège, Belgium

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Plovdiv, Bulgaria

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Rousse, Bulgaria

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Sofia, Bulgaria

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Barranquilla, Colombia

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Bogotá, Colombia

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Bucaramanga, Colombia

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Medellín, Colombia

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Bordeaux, France

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Hamburg, Germany

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Leipzig, Germany

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Würzburg, Germany

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Siena, Italy

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Udine, Italy

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Chihuahua City, Mexico

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Cuernava, Mexico

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Del. Cuauhtemoc, Mexico

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Guadalajara, Mexico

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León, Mexico

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Mexcio, Mexico

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México, Mexico

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Morelia, Mexico

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San Luis Potosí City, Mexico

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Jesus Maria, Peru

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Lima, Peru

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Bialystok, Poland

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Bytom, Poland

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Elblag, Poland

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Grodzisk Mazowiecki, Poland

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Krakow, Poland

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Lublin, Poland

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Torun, Poland

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Wroclaw, Poland

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Zyrardów, Poland

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Brailari, Romania

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Bucharest, Romania

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Cluj-Napoca, Romania

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Sf. Gheorghe, Romania

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Sibiu, Romania

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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

• Chris O'Brien, MD, PhD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

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

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 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 25, 2014
• Results First Posted: June 25, 2014

Record last verified: 2014-05

Locations

RO (5); CO (4); PE (2); IT (2); DE (3); BU (3); ME (9); BE (3); FR (1); PL (9); US (35)