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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:  NCT00665925
Date of registration: 22/04/2008
Prospective Registration: Yes
Primary sponsor: Rigel Pharmaceuticals
Public title: Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis Taski-2
Scientific title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate
Date of first enrolment: May 2008
Target sample size: 457
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00665925
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Bulgaria Colombia Israel Mexico Poland Romania United States
Contacts
Name:     Daniel B Magilavy, MD
Address: 
Telephone:
Email:
Affiliation:  Rigel Pharmaceuticals
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.

- Males and females, 18 years of age or older, with active RA for at least 6 months
prior to Day 1 dosing.

- Patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a
minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose,
with no change in route, for the previous 6 weeks prior to Day 1 dosing.

`Patients must be receiving a folic or folinic acid supplementation at a stable dose
for at least 6 weeks prior to Day 1 dosing.

- 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 urine pregnancy test at the time of randomization and at each
laboratory determination.

- The patient must otherwise be in good health as determined by the Investigator on the
basis of medical history, physical examination, and laboratory screening tests during
the screening period. See exclusion criteria for specific exclusions.

- In the Investigator's opinion, the patient has the ability to understand the nature of
the study and any hazards of participation, and to communicate satisfactorily with the
Investigator and to participate in, and to comply with, the requirements of the entire
protocol.

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. uncontrolled or poorly controlled hypertension;

2. other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder)
or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);

3. recent (within past 2 months prior to Day 1 dosing) serious surgery or infectious
disease;

4. recent history (past 5 years prior to Day 1 dosing) of, or treatment for, a
malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;

5. Hepatitis B ;

6. Hepatitis C ;

7. interstitial pneumonitis or active pulmonary infection on chest x-ray;

8. Tuberculosis (TB): the TB skin test should be negative.

9. known laboratory abnormalities.

- 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 has been treated previously treated with R788 under a different 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)
Drug: Placebo
Primary Outcome(s)
American College of Rheumatology 20 (ACR20) Response at 6 Months [Time Frame: 6 months]
Secondary Outcome(s)
Absolute Neutrophil Count (ANC) <1500/mm3 [Time Frame: Any time between baseline and 6 months]
Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times Baseline [Time Frame: Any time between baseline and 6 months]
American College of Rheumatology 20 (ACR20) Response at 1 Month [Time Frame: 1 month]
American College of Rheumatology 20 (ACR20) Response at 1 Week [Time Frame: 1 week]
American College of Rheumatology 20 (ACR20) Response at 2 Months [Time Frame: 2 months]
American College of Rheumatology 20 (ACR20) Response at 2 Weeks [Time Frame: 2 weeks]
American College of Rheumatology 20 (ACR20) Response at 3 Months [Time Frame: 3 months]
American College of Rheumatology 20 (ACR20) Response at 4 Months [Time Frame: 4 months]
American College of Rheumatology 20 (ACR20) Response at 5 Months [Time Frame: 5 months]
American College of Rheumatology 20 (ACR20) Response at 6 Weeks [Time Frame: 6 weeks]
American College of Rheumatology 50 (ACR50) Response at 1 Month [Time Frame: 1 month]
American College of Rheumatology 50 (ACR50) Response at 1 Week [Time Frame: 1 week]
American College of Rheumatology 50 (ACR50) Response at 2 Months [Time Frame: 2 months]
American College of Rheumatology 50 (ACR50) Response at 2 Weeks [Time Frame: 2 weeks]
American College of Rheumatology 50 (ACR50) Response at 3 Months [Time Frame: 3 months]
American College of Rheumatology 50 (ACR50) Response at 4 Months [Time Frame: 4 months]
American College of Rheumatology 50 (ACR50) Response at 5 Months [Time Frame: 5 months]
American College of Rheumatology 50 (ACR50) Response at 6 Months [Time Frame: 6 months]
American College of Rheumatology 50 (ACR50) Response at 6 Weeks [Time Frame: 6 weeks]
American College of Rheumatology 70 (ACR70) Response at 1 Month [Time Frame: 1 month]
American College of Rheumatology 70 (ACR70) Response at 1 Week [Time Frame: 1 week]
American College of Rheumatology 70 (ACR70) Response at 2 Months [Time Frame: 2 months]
American College of Rheumatology 70 (ACR70) Response at 2 Weeks [Time Frame: 2 weeks]
American College of Rheumatology 70 (ACR70) Response at 3 Months [Time Frame: 3 months]
American College of Rheumatology 70 (ACR70) Response at 4 Months [Time Frame: 4 months]
American College of Rheumatology 70 (ACR70) Response at 5 Months [Time Frame: 5 months]
American College of Rheumatology 70 (ACR70) Response at 6 Months [Time Frame: 6 months]
American College of Rheumatology 70 (ACR70) Response at 6 Weeks [Time Frame: 6 weeks]
American College of Rheumatology Index of Improvement (ACRn) at 1 Month [Time Frame: 1 month]
American College of Rheumatology Index of Improvement (ACRn) at 1 Week [Time Frame: 1 week]
American College of Rheumatology Index of Improvement (ACRn) at 2 Months [Time Frame: 2 months]
American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks [Time Frame: 2 weeks]
American College of Rheumatology Index of Improvement (ACRn) at 3 Months [Time Frame: 3 months]
American College of Rheumatology Index of Improvement (ACRn) at 4 Months [Time Frame: 4 months]
American College of Rheumatology Index of Improvement (ACRn) at 5 Months [Time Frame: 5 months]
American College of Rheumatology Index of Improvement (ACRn) at 6 Months [Time Frame: 6 months]
American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks [Time Frame: 6 weeks]
Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Aspartate Aminotransferase (AST) >5-10 x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Bilirubin >1.5 x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Bilirubin >2 x Upper Limit of Normal (ULN) [Time Frame: Any time between baseline and 6 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month [Time Frame: 1 month]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 Months [Time Frame: 2 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months [Time Frame: 3 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 Months [Time Frame: 4 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 Months [Time Frame: 5 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 Months [Time Frame: 6 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month [Time Frame: 1 month]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 Months [Time Frame: 2 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months [Time Frame: 3 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 Months [Time Frame: 4 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 Months [Time Frame: 5 months]
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 Months [Time Frame: 6 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month [Time Frame: 1 month]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 Months [Time Frame: 2 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months [Time Frame: 3 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 Months [Time Frame: 4 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 Months [Time Frame: 5 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 Months [Time Frame: 6 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month [Time Frame: 1 month]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 Months [Time Frame: 2 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months [Time Frame: 3 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 Months [Time Frame: 4 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 Months [Time Frame: 5 months]
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 Months [Time Frame: 6 months]
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months [Time Frame: Baseline to 6 months]
Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months [Time Frame: Baseline to 6 months]
Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months [Time Frame: Baseline to 6 months]
Secondary ID(s)
C-935788-010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 13/06/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00665925
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