Rheumatoid ArthritisPhase 2Taski-3NCT00665626
Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-3)
A Phase 2 study testing Fostamatinib disodium (R935788) in people with Rheumatoid Arthritis, run by Rigel Pharmaceuticals at 44 sites in 7 countries.
Trial summary
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Fostamatinib disodium (R935788)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 44 sitesin 7 countries
- Study dates
- May 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 12 months prior to Day 1 dosing
- Are currently receiving or previously had received a biologic therapy with an inhibitor of TNF, rituximab, abatacept, or anakinra at an approved labeled dose for ≥3 months prior to Day 1 dosing and are designated as biologic therapy failures for lack of efficacy, safety, or tolerability.
- Patients may receive stable doses of methotrexate (MTX), azathioprine (not in combination with MTX), leflunomide (not in combination with MTX), sulfasalazine, chloroquine, hydroxychloroquine, gold, NSAIDs (including COX2 inhibitors), minocycline, or doxycycline. The dose must have been stable for at least 30 days prior to Day 1 dosing and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements. Patients who are taking MTX must have been receiving weekly MTX 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 who are receiving MTX must also be receiving 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.
Who cannot join
- 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:
- uncontrolled or poorly controlled hypertension;
- other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter's syndrome);
- recent serious surgery or infectious disease;
- recent history ( of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
- Hepatitis B;
Show all 13Show fewer
- Hepatitis C;
- interstitial pneumonitis or active pulmonary infection on chest x-ray
- Tuberculosis (TB)
- 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.
- The patient has a pacemaker, aneurysm clip or other contraindication to MRI.
Trial locations and contacts
44 sites in 7 countries.
44 sites in 7 countries
United States27 sites
Austin Rheumatology & Research
Austin, Texas, 78705
Arthritis & Rheumatic Disease Specialties
Aventura, California, 33180
RASF-Clinical Research Center
Boca Raton, Florida, 33486
Intermountain Orthopedics
Boise, Idaho, 83702
Rheumatology Associates, SC
Chicago, Illinois, 60612
The Osteoporosis & Clinical Trials Center
Cumberland, Maryland, 21502
Center for Arthritis & Osteoperosis
Elizabethtown, Kentucky, 42701
Rheumatology Associates
Erie, Pennsylvania, 16508
Florida Medical Research Institute
Gainsville, Florida, 32607
The Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, 21740
Houston Institute for Clinical Research
Houston, Texas, 77074
North Shore Long Island Jewich Health System
Lake Success, New York, 11042
Fiechtner Research, Inc.
Lansing, Michigan, 48910
Clinical Research Division
Mayfield Village, Ohio, 44143
Paddock Park Clinical Research
Ocala, Florida, 34474
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103
Westroads Medical Group
Omaha, Nebraska, 68114
Desert Medical Advances
Palm Desert, California, 92260
Andrew Porges, MD PC
Roslyn, New York, 11576
San Diego Arthritis & Medical Clinic
San Diego, California, 92108
Lovelace Scientific Resources
Sarasota, Florida, 34233
Rheumatology Associates of Long Island
Smithtown, New York, 11787
Memorial Medical Group Clinical Research Inst
South Bend, Indiana, 46601
Arthritis Northwest, PLLC
Spokane, Washington, 99204
Department of Rheumatology
Washington D.C., District of Columbia, 20010
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 34474
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
Colombia5 sites
Reumatologos del Caribe
Barranquilla, Atlántico
CIREEM
Bogota, Cundinamarca
Dr. Renato Guzman
Bogota, Cundinamarca
Riesgo de Fractura S.A.
Bogota, Cundinamarca
Reumalab S.A.
Medellín, Antioquia
Germany5 sites
Klinikum der J.W. Goethe Universitaet
Frankfurt, 60590
Klinikum Eilbek
Hamburg, 22081
ClinPharm International GmbH Leipzig
Leipzig, 04103
Rheumazentrum am Universitatsklinikum Leipzig
Leipzig, 04103
Universitatsklinikum Wurzburg
Würzburg, 97070
Belgium3 sites
ZNA Middelheim
Antwepen, 2020
UZ Gent
Ghent, 9000
CHU Liege
Liège, 4000
Italy2 sites
Reumatologia Azienda Ospedaliera Universitaria
Siena, 53100
Azienda Ospedaliera Santa Maria della Miseri
Udine, 33100
About this study
Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Fostamatinib disodium (R935788), Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostamatinib disodium (R935788)Drug
R935788 100 mg tablet, orally, twice-a-day
PlaceboDrug
Placebo, orally, twice-a-day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Fostamatinib disodium (R935788) 100 mg tablet, orally, twice-a-day Receives: Drug: Fostamatinib disodium (R935788) |
| Arm 2 | Placebo comparator | Placebo, orally, twice-a-day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20 (ACR20) Response at 3 Months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months
Measured: 3 months
Secondary outcomes (30)
American College of Rheumatology 50 (ACR50) Response at 3 Months
The number of participants with greater than or equal to 50% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months
Measured: 3 months
American College of Rheumatology 70 (ACR70) Response at 3 Months
The number of participants with greater than or equal to 70% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 3 months
Measured: 3 months
American College of Rheumatology Index of Improvement (ACRn) at 3 Months
The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA after 3 months of treatment
Measured: 3 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 3 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 3 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 3 Months
Number of participants with DAS28-CRP (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and CRP in patients with high CRP at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.
Measured: 3 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 3 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 2.6. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 2.6 indicates remission of RA symptoms
Measured: 3 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 3 Months
Number of participants with DAS28-ESR (measuring RA symptoms including: tender joint count, swollen joint count, patient's assessment of disease activity, and ESR in patients with high ESR at baseline), of less than 3.2. The DAS runs from 0 to 10 - higher scores indicate worse symptoms. A score of less than 3.2 indicates low disease activity.
Measured: 3 months
American College of Rheumatology 20 (ACR20) Response at Week 1
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 1 week.
Measured: 1 week
American College of Rheumatology 20 (ACR20) Response at Week 2
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, HAQ-DI; and CRP or ESR, whichever was elevated at baseline, after 2 weeks
Measured: 2 weeks
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Erosion Score at 3 Months
Change from baseline in RAMRIS erosion score (a measure of bone erosion in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The erosion score runs from 0 to 250 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.
Measured: Baseline to 3 months
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Osteitis Score at 3 Months
Change from baseline in RAMRIS osteitis score (a measure of bone inflammation in the hands and wrists), calculated as the score at 3 months minus the score at baseline. The osteitis score runs from 0 to 75 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.
Measured: Baseline to 3 months
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Synovitis Score at 3 Months
Change from baseline in RAMRIS synovitis score (a measure of inflammation in the joints of the hands and wrists), calculated as the score at 3 months minus the score at baseline. The synovitis score runs from 0 to 24 with lower values indicating a better clinical condition. A negative change indicates an improvement in symptoms.
Measured: Baseline to 3 months
Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 1.5 times the ULN
Measured: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 1.5 to 2 times the ULN
Measured: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 2 to 3 times the ULN
Measured: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 3 times the ULN
Measured: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 3 to 5 times the ULN
Measured: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 5 to 10 times the ULN
Measured: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)
The number of participants with ALT (a test of liver function) values greater than 10 times the ULN
Measured: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 1.5 times the ULN
Measured: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 1.5 to 2 times the ULN
Measured: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 2 to 3 times the ULN
Measured: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 3 times the ULN
Measured: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 3 to 5 times the ULN
Measured: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >5-10x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 5 to 10 times the ULN
Measured: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >10x Upper Limit of Normal (ULN)
The number of participants with AST (a test of liver function) values greater than 10 times the ULN
Measured: Any time between baseline and 3 months
Alkaline Phosphatase >1.5x Upper Limit of Normal (ULN) and >1.5x Baseline
The number of participants with alkaline phosphatase (a test of liver function) values greater than 1.5 times the ULN and greater than 1.5 times baseline
Measured: Any time between baseline and 3 months
Bilirubin >1.5x Upper Limit of Normal (ULN)
The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN
Measured: Any time between baseline and 3 months
Bilirubin >2x Upper Limit of Normal (ULN)
The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN
Measured: Any time between baseline and 3 months
Absolute Neutrophil Count (ANC) <1500/mm3
The number of participants with ANC values less than 1500/mm3
Measured: Any time between baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel B Magilavy, MD, Study director, Rigel Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665626
- Sponsor's protocol ID
- C-935788-011
- Acronym
- Taski-3
- Status last verified
- Mar 2017
- First submitted
- 22 Apr 2008
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic
- ClinicalTrials.gov ID
- NCT00665626
- Acronym / sponsor ID
- Taski-3 / C-935788-011
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Posted 15 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) Inhibitor, R935788 (R788) at a dose of 100 mg, tablet, orally, twice-a-day is effective in the treatment of Rheumatoid Arthritis in patients who have 'failed' a biologic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Fostamatinib disodium (R935788)Fostamatinib disodium (R935788) 100 mg tablet, orally, twice-a-day |
| Arm 2 | Placebo comparator | Drug: PlaceboPlacebo, orally, twice-a-day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 12 months prior to Day 1 dosing
- Are currently receiving or previously had received a biologic therapy with an inhibitor of TNF, rituximab, abatacept, or anakinra at an approved labeled dose for ≥3 months prior to Day 1 dosing and are designated as biologic therapy failures for lack of efficacy, safety, or tolerability.
- Patients may receive stable doses of methotrexate (MTX), azathioprine (not in combination with MTX), leflunomide (not in combination with MTX), sulfasalazine, chloroquine, hydroxychloroquine, gold, NSAIDs (including COX2 inhibitors), minocycline, or doxycycline. The dose must have been stable for at least 30 days prior to Day 1 dosing and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements. Patients who are taking MTX must have been receiving weekly MTX 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 who are receiving MTX must also be receiving 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.
Key exclusion criteria (13 listed)
- 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:
- 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.
- The patient has a pacemaker, aneurysm clip or other contraindication to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fostamatinib disodium (R935788)R935788 100 mg tablet, orally, twice-a-day | Drug | Arm 1 |
| PlaceboPlacebo, orally, twice-a-day | Drug | Arm 2 |
Primary outcome
American College of Rheumatology 20 (ACR20) Response at 3 Months
Time frame: 3 months
The number of participants with greater than or equal to 20% improvement in tender and swollen joint counts, AND in any 3 of the following: physician's assessment of disease activity, patient's assessment of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI); and CRP or ESR, after 3 months
30 secondary outcomes
American College of Rheumatology 50 (ACR50) Response at 3 Months
Time frame: 3 months
American College of Rheumatology 70 (ACR70) Response at 3 Months
Time frame: 3 months
American College of Rheumatology Index of Improvement (ACRn) at 3 Months
Time frame: 3 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) <3.2 at 3 Months
Time frame: 3 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) <3.2 at 3 Months
Time frame: 3 months
American College of Rheumatology 20 (ACR20) Response at Week 1
Time frame: 1 week
American College of Rheumatology 20 (ACR20) Response at Week 2
Time frame: 2 weeks
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Erosion Score at 3 Months
Time frame: Baseline to 3 months
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Osteitis Score at 3 Months
Time frame: Baseline to 3 months
Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) Synovitis Score at 3 Months
Time frame: Baseline to 3 months
Alanine Aminotransferase (ALT) >1.5x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >1.5-2x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >2-3x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >3x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >3-5x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >5-10x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Alanine Aminotransferase (ALT) >10x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >1.5x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >1.5-2x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >2-3x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >3x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >3-5x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >5-10x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Aspartate Aminotransferase (AST) >10x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Alkaline Phosphatase >1.5x Upper Limit of Normal (ULN) and >1.5x Baseline
Time frame: Any time between baseline and 3 months
Bilirubin >1.5x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Bilirubin >2x Upper Limit of Normal (ULN)
Time frame: Any time between baseline and 3 months
Absolute Neutrophil Count (ANC) <1500/mm3
Time frame: Any time between baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Magilavy, MD study director
Rigel Pharmaceuticals
44 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fostamatinib disodium (R935788) in people with Rheumatoid Arthritis, run by Rigel Pharmaceuticals at 44 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Colombia, Germany, Belgium, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology 20 (ACR20) Response at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.