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

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients With Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805467
• Other study ID #: C-935788-012
• Secondary ID: D4300C00021
• Status: Terminated
• Phase: Phase 2
• First received: December 5, 2008
• Last updated: May 23, 2014
• Start date: August 2008
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardBulgaria: Bulgarian Drug AgencyColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosColombia: Ethics Committee (Ethic Committee of each institution)Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthMexico: Ethics Committee (each site submits to their local EC).Mexico: Federal Commission for Protection Against Health RisksMexico: Federal Commission for Sanitary Risks ProtectionMexico: Ministry of Health (Secretaria de Salud, SSA)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 624
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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:

1. unresolved Grade 2 or greater toxicity in a RA protocol studying R788

2. uncontrolled or poorly controlled hypertension;

3. recent (within past 2 months) serious surgery or infectious disease;

4. 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;

5. known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;

6. interstitial pneumonitis or active pulmonary infection;

7. 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Fostamatinib Disodium (R935788)
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD

Locations

Country	Name	City	State
Belgium	Research Site	Antwerp
Belgium	Research Site	Gent
Belgium	Research Site	Liege
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Colombia	Research Site	Bucaramanga
Colombia	Research Site	Medellín
France	Research Site	Bordeaux
Germany	Research Site	Hamburg
Germany	Research Site	Leipzig
Germany	Research Site	Würzburg
Italy	Research Site	Siena
Italy	Research Site	Udine
Mexico	Research Site	Chihuahua
Mexico	Research Site	Cuernava
Mexico	Research Site	Del. Cuauhtemoc
Mexico	Research Site	Guadalajara
Mexico	Research Site	Leon
Mexico	Research Site	Mexcio
Mexico	Research Site	Mexico
Mexico	Research Site	Morelia
Mexico	Research Site	San Luis Potosí
Peru	Research Site	Jesus Maria
Peru	Research Site	Lima
Poland	Research Site	Bialystok
Poland	Research Site	Bytom
Poland	Research Site	Elblag
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Torun
Poland	Research Site	Wroclaw
Poland	Research Site	Zyrardów
Romania	Research Site	Brailari
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Sf. Gheorghe
Romania	Research Site	Sibiu
United States	Research Site	Austin	Texas
United States	Research Site	Aventura	Florida
United States	Research Site	Boca Raton	Florida
United States	Research Site	Boise	Idaho
United States	Research Site	Coeur D'Alene	Idaho
United States	Research Site	Cumberland	Maryland
United States	Research Site	Elizabethtown	Kentucky
United States	Research Site	Erie	Pennsylvania
United States	Research Site	Gainesville	Florida
United States	Research Site	Hagerstown	Maryland
United States	Research Site	Hamden	Connecticut
United States	Research Site	Jackson	Tennessee
United States	Research Site	La Jolla	California
United States	Research Site	Lansing	Michigan
United States	Research Site	Mayfiled Village	Ohio
United States	Research Site	Ocala	Florida
United States	Research Site	Oklahoma City	Washington
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orange Park	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Palm Desert	California
United States	Research Site	Palo Alto	California
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Roslyn	New York
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Santa Maria	California
United States	Research Site	Smithtown	New York
United States	Research Site	South Bend	Indiana
United States	Research Site	South Miami	Florida
United States	Research Site	Spokane	Washington
United States	Research Site	Venice	Florida
United States	Research Site	Washington	District of Columbia
United States	Research Site	Willow Grove	Pennsylvania
United States	Research Site	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Colombia,  France,  Germany,  Italy,  Mexico,  Peru,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	DAS28-CRP Score	The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily	3 years	No
Secondary	HAQ-DI Score	Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.	3 years	No