Clinical trial NCT00805467: Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: RA
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
timeFrame: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)
Secondary outcomes:
measure: DAS28-CRP Score
timeFrame: 3 years
measure: HAQ-DI Score
timeFrame: 3 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Research Site
state: California
city: Palm Desert
country: United States
facility: Research Site
state: California
city: Palo Alto
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Maria
country: United States
facility: Research Site
state: California
city: Hamden
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Orange Park
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: South Miami
country: United States
facility: Research Site
state: Florida
city: Venice
country: United States
facility: Research Site
state: Florida
city: Boise
country: United States
facility: Research Site
state: Idaho
city: Coeur D'Alene
country: United States
facility: Research Site
state: Idaho
city: South Bend
country: United States
facility: Research Site
state: Indiana
city: Elizabethtown
country: United States
facility: Research Site
state: Kentucky
city: Cumberland
country: United States
facility: Research Site
state: Maryland
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Roslyn
country: United States
facility: Research Site
state: New York
city: Smithtown
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Mayfiled Village
country: United States
facility: Research Site
state: Ohio
city: Erie
country: United States
facility: Research Site
state: Pennsylvania
city: Willow Grove
country: United States
facility: Research Site
state: Pennsylvania
city: Wyomissing
country: United States
facility: Research Site
state: Pennsylvania
city: Jackson
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Oklahoma City
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Antwerp
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bucaramanga
country: Colombia
facility: Research Site
city: Medellín
country: Colombia
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Würzburg
country: Germany
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Udine
country: Italy
facility: Research Site
city: Chihuahua
country: Mexico
facility: Research Site
city: Cuernava
country: Mexico
facility: Research Site
city: Del. Cuauhtemoc
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Leon
country: Mexico
facility: Research Site
city: Mexcio
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Morelia
country: Mexico
facility: Research Site
city: San Luis Potosí
country: Mexico
facility: Research Site
city: Jesus Maria
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Toruń
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zyrardów
country: Poland
facility: Research Site
city: Brailari
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Sf. Gheorghe
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Chris O'Brien, MD, PhD
role: STUDY_DIRECTOR
References: