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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00805467
Date of registration: 05/12/2008
Prospective Registration: Yes
Primary sponsor: AstraZeneca
Public title: Open-Label, Multicenter Extension Study for Patients Completing Treatment Phase of a Rigel-Sponsored R935788 Studies
Scientific 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
Date of first enrolment: August 2008
Target sample size: 624
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT00805467
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Belgium Bulgaria Colombia France Germany Italy Mexico Peru
Poland Romania United States
Contacts
Name:     Chris O'Brien, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  AstraZeneca
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Fostamatinib Disodium (R935788)
Primary Outcome(s)
Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category [Time Frame: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)]
Secondary Outcome(s)
DAS28-CRP Score [Time Frame: 3 years]
HAQ-DI Score [Time Frame: 3 years]
Secondary ID(s)
C-935788-012
D4300C00021
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 25/06/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00805467
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