Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis (Taski-2)

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

The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Fostamatinib disodium (R935788); Drug: Fostamatinib disodium (R935788); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 457
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Ruse, Bulgaria, 7002
    • MHAT Ruse
  • Sofia, Bulgaria, 1709
    • DCC "Sv. Anna" Sofia
  • Gsof
    • Sofia, Gsof, Bulgaria
      • MNTranspH "Tsar Boris Treti"
  • PLO
    • Plovdiv, PLO, Bulgaria, 4002
      • MHAT "Kaspela"
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Unidad Medica Torre Plaza
  • Atlántico
    • Barranquilla, Atlántico, Colombia
      • Centro de Reumatologia y Ortopedia
    • Barranquilla, Atlántico, Colombia
      • Reumatologos del Caribe
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • CIREEM
    • Bogota, Cundinamarca, Colombia
      • Riesgo De Fractura S.A
    • Bogota, Cundinamarca, Colombia
      • Fundación Instituto de Reumatología
    • Bogotá, Cundinamarca, Colombia
      • Private office
  • Santander
    • Bucaramanga, Santander, Colombia
      • Centro Medico Carlos Ardila Lulle
    • Bucaramanga, Santander, Colombia
      • SERVIMED
• Mexico
  • Chihuahua, Mexico, 31000
    • Christus Muguerza del Parque
  • D.f.
    • Mexico, D.f., Mexico, 6700
      • Arké Estudios Clínicos S.A de C.V
    • Mexico, D.f., Mexico, 6700
      • Clínica para el Diagnostico y Tratamiento de
    • Mexico, D.f., Mexico, 6700
      • Hospital Ángeles Metropolitano
    • Mexico, D.f., Mexico, 6726
      • Hospital General de Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 6760
      • Centro Medico Dalinde
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • Hospital Aranda de La Parra
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44100
      • Instituto Jalisciense de Investigación Clínica
    • Guadalajara, Jalisco, Mexico, 44280
      • Hospital Civil de Guadalajara "Fray Antonio A
  • Michoacan
    • Morelia, Michoacan, Mexico
      • Centro de Investigacion Clinical de Morelia
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62270
      • Hospital Inovamed , Torre Médica
• Poland
  • Bialystok, Poland, 15-337
    • NZOZ Centrum Medyczne Artur Racewicz
  • Bytom, Poland, 41-902
    • Szpit. Spec.Nr 1, Odz. Reumatol. i Reh.
  • Elblag, Poland, 82-300
    • Wojewodzki Szpital Zespolony Oddzial Reumatol
  • Grodzisk Mazowiecki, Poland
    • Mazowieckie Centrum Badan Klinicznych
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne NZOZ
  • Krakow, Poland, 30-510
    • Malopolskie Centrum Medyczne Sc
  • Lublin, Poland, 20-607
    • NZOZ Reumed
  • Torun, Poland, 87-100
    • NZOZ "Nasz Lekarz"
  • Wroclaw, Poland, 50-088
    • Synexus SCM
  • Wroclaw, Poland, 53-137
    • ASK Klinika Reumatologii i Chor. Wewn.
  • Zyradow, Poland, 96-300
    • ZOZ w Zyradowie Oddzial Reumatologii
• Romania
  • Braila, Romania, 810219
    • CMI "Cristei R. Dorica"
  • Bucuresti, Romania, 021392
    • Spitalul de Urgenta al MAI Dr. D. Gerota
  • Sf. Gheorghe, Romania, 520064
    • Spitalul Judetean "Dr. Fogolyan Kristol"
  • Sibiu, Romania, 550245
    • Spitalul Clinic Judetean Sibiu
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400006
      • Spitalul Clinic Judetean de Urgenta Cluj Reum
  • Sector 1
    • Bucuresti, Sector 1, Romania, 11172
      • Spitalul Clinic "Sf. Maria" Med Int si Reumat
• United States
  • California
    • La Jolla, California, United States, 92037
      • Divison of Rheumatology Allergy and Immunology
    • Palm Desert, California, United States, 92260
      • Desert Medical Advances
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Arthritis & Osteoporosis Center, PC
  • District of Columbia
    • Washington, District of Columbia, United States, 20003
      • Cynthia Morgan
  • Florida
    • Gainsville, Florida, United States, 32607
      • Florida Medical Research Institute
    • Ocala, Florida, United States, 34474
      • Paddock Park Clinical Research
    • Orlando, Florida, United States, 32804
      • Jeffrey Poiley, MD
    • Sarasota, Florida, United States, 34233
      • Lovelace Scientific Resources
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rheumatology Associates, SC
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Memorial Medical Group Clinical Research Inst
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
      • Center for Arthritis & Osteoporosis
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • The Osteoporosis & Clinical Trials Center
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Fiechtner Research, Inc.
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Westroads Medical Group
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • North Carolina Arthritis & Allergy Care Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Oklahoma
    • Oklahoma, Oklahoma, United States, 73103
      • Health Research of Oklahoma
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16508
      • Rheumatology Associates
    • West Reading, Pennsylvania, United States, 19611
      • Clinical Research Center of Reading, LLP
    • Willow Grove, Pennsylvania, United States, 19090
      • Rheumatic Disease Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Rheumatology Associates
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Rheumatology & Research
    • San Antonio, Texas, United States, 78232
      • Arthritis Center of South Texas
  • Washington
    • Spokane, Washington, United States, 99204
      • Arthritis Northwest, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; R788, 100 mg tablet, orally, twice-a-day	Drug: Fostamatinib disodium (R935788); 100 mg tablet, orally, twice-a-day; Other Names: R935788; Drug: Fostamatinib disodium (R935788); 150 mg tablet, orally, once a day; Other Names: R935788
Experimental: 2; R788, 150 mg tablet, orally, once a day	Drug: Fostamatinib disodium (R935788); 100 mg tablet, orally, twice-a-day; Other Names: R935788; Drug: Fostamatinib disodium (R935788); 150 mg tablet, orally, once a day; Other Names: R935788
Placebo Comparator: 3; Placebo, orally, either once a day, or twice a day	Drug: Placebo; Placebo, orally, either once a day, or twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American College of Rheumatology 20 (ACR20) Response at 6 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, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	3 months
American College of Rheumatology 20 (ACR20) Response at 1 Week	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week	1 week
American College of Rheumatology 20 (ACR20) Response at 2 Weeks	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks	2 weeks
American College of Rheumatology 20 (ACR20) Response at 1 Month	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month	1 month
American College of Rheumatology 20 (ACR20) Response at 6 Weeks	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks	6 weeks
American College of Rheumatology 20 (ACR20) Response at 2 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, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months	2 months
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, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months	3 months
American College of Rheumatology 20 (ACR20) Response at 4 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, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months	4 months
American College of Rheumatology 20 (ACR20) Response at 5 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, HAQ-DI; and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months	5 months
American College of Rheumatology 50 (ACR50) Response at 1 Week	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week	1 week
American College of Rheumatology 50 (ACR50) Response at 2 Weeks	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks	2 weeks
American College of Rheumatology 50 (ACR50) Response at 1 Month	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month	1 month
American College of Rheumatology 50 (ACR50) Response at 6 Weeks	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks	6 weeks
American College of Rheumatology 50 (ACR50) Response at 2 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months	2 months
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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months	3 months
American College of Rheumatology 50 (ACR50) Response at 4 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months	4 months
American College of Rheumatology 50 (ACR50) Response at 5 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months	5 months
American College of Rheumatology 50 (ACR50) Response at 6 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months	6 months
American College of Rheumatology 70 (ACR70) Response at 1 Week	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 week	1 week
American College of Rheumatology 70 (ACR70) Response at 2 Weeks	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 weeks	2 weeks
American College of Rheumatology 70 (ACR70) Response at 1 Month	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 1 month	1 month
American College of Rheumatology 70 (ACR70) Response at 6 Weeks	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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 weeks	6 weeks
American College of Rheumatology 70 (ACR70) Response at 2 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 2 months	2 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 3 months	3 months
American College of Rheumatology 70 (ACR70) Response at 4 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 4 months	4 months
American College of Rheumatology 70 (ACR70) Response at 5 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 5 months	5 months
American College of Rheumatology 70 (ACR70) Response at 6 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 C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR), after 6 months	6 months
American College of Rheumatology Index of Improvement (ACRn) at 1 Week	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 1 week of treatment	1 week
American College of Rheumatology Index of Improvement (ACRn) at 2 Weeks	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 2 weeks of treatment	2 weeks
American College of Rheumatology Index of Improvement (ACRn) at 1 Month	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 1 month of treatment	1 month
American College of Rheumatology Index of Improvement (ACRn) at 6 Weeks	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 6 weeks of treatment	6 weeks
American College of Rheumatology Index of Improvement (ACRn) at 2 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 2 months of treatment	2 months
American College of Rheumatology Index of Improvement (ACRn) at 4 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 4 months of treatment	4 months
American College of Rheumatology Index of Improvement (ACRn) at 5 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 5 months of treatment	5 months
American College of Rheumatology Index of Improvement (ACRn) at 6 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 6 months of treatment	6 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 1 Month	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	1 month
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 2 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	2 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 4 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	4 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 5 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	5 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <2.6 at 6 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	6 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 1 Month	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	1 month
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 2 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	2 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	3 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 4 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	4 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 5 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	5 months
Disease Activity Score-C-Reactive Protein (DAS28-CRP) <3.2 at 6 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	6 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 1 Month	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	1 month
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 2 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	2 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 4 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	4 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 5 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	5 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <2.6 at 6 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	6 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 1 Month	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	1 month
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 2 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	2 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	3 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 4 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	4 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 5 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	5 months
Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) <3.2 at 6 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	6 months
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at 6 Months	Change from baseline in FACIT-F, which is a patient-reported 13-item questionnaire that assesses fatigue, calculated as the score at 6 months minus the score at baseline. The FACIT-F runs from 0 to 52 with lower scores indicating higher fatigue. A positive change from baseline indicates an improvement in fatigue after treatment.	Baseline to 6 months
Short Form Health Survey (SF-36) Physical Component Summary (PCS) at 6 Months	Change from baseline in the PCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The PCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in PCS after treatment	Baseline to 6 months
Short Form Health Survey (SF-36) Mental Component Summary (MCS) at 6 Months	Change from baseline in the MCS of the SF-36 (which assesses health and wellbeing), calculated as the score at 6 months minus the score at baseline. The MCS ranges from 0 to 100 with 100 indicating the highest level of functioning possible. A positive change indicates an improvement in MCS after treatment	Baseline to 6 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	Any time between baseline and 6 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	Any time between baseline and 6 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	Any time between baseline and 6 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	Any time between baseline and 6 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	Any time between baseline and 6 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	Any time between baseline and 6 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	Any time between baseline and 6 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	Any time between baseline and 6 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 1.5-2 times the ULN	Any time between baseline and 6 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	Any time between baseline and 6 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	Any time between baseline and 6 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	Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >5-10 x 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	Any time between baseline and 6 months
Aspartate Aminotransferase (AST) >10 x Upper Limit of Normal (ULN)	The number of participants with AST (a test of liver function) values greater than 10 times the ULN	Any time between baseline and 6 months
Alkaline Phosphatase >1.5 x Upper Limit of Normal (ULN) and >1.5 Times 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	Any time between baseline and 6 months
Bilirubin >1.5 x Upper Limit of Normal (ULN)	The number of participants with bilirubin (a test of liver function) values greater than 1.5 times the ULN	Any time between baseline and 6 months
Bilirubin >2 x Upper Limit of Normal (ULN)	The number of participants with bilirubin (a test of liver function) values greater than 2 times the ULN	Any time between baseline and 6 months
Absolute Neutrophil Count (ANC) <1500/mm3	The number of participants with ANC (a test of liver function) values lower than 1500/mm3	Any time between baseline and 6 months

Collaborators and Investigators

• Sponsor: Rigel Pharmaceuticals
• Investigators: Study Director: Daniel B Magilavy, MD, Rigel Pharmaceuticals

Publications and helpful links

General Publications

• Weinblatt ME, Kavanaugh A, Genovese MC, Musser TK, Grossbard EB, Magilavy DB. An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis. N Engl J Med. 2010 Sep 30;363(14):1303-12. doi: 10.1056/NEJMoa1000500. Epub 2010 Sep 22.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: April 22, 2008
• First Submitted That Met QC Criteria: April 23, 2008
• First Posted (Estimate): April 24, 2008

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: August 5, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: C-935788-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO