Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis

NCT00665925 | Completed Phase 2 Results DMC

• 1 other identifier: C-935788-010
• Study Type: interventional
• Target: 457
• Locations: 6 countries
• Sites: 65

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (80)

• American College of Rheumatology 20 (ACR20) Response at 1 Week

  1 week

• American College of Rheumatology 20 (ACR20) Response at 2 Weeks

  2 weeks

• American College of Rheumatology 20 (ACR20) Response at 1 Month

  1 month

• American College of Rheumatology 20 (ACR20) Response at 6 Weeks

  6 weeks

• American College of Rheumatology 20 (ACR20) Response at 2 Months

  2 months

Study Arms (3)

1

EXPERIMENTAL

R788, 100 mg tablet, orally, twice-a-day

Drug: Fostamatinib disodium (R935788)

2

EXPERIMENTAL

R788, 150 mg tablet, orally, once a day

Drug: Fostamatinib disodium (R935788)

3

PLACEBO COMPARATOR

Placebo, orally, either once a day, or twice a day

Drug: Placebo

Interventions

Fostamatinib disodium (R935788) DRUG

100 mg tablet, orally, twice-a-day

Also known as: R935788

1

Placebo DRUG

Placebo, orally, either once a day, or twice a day

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease;
• 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;
• Hepatitis B ;
• Hepatitis C ;
• interstitial pneumonitis or active pulmonary infection on chest x-ray;
• Tuberculosis (TB): the TB skin test should be negative.
• 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.

Sponsors & Collaborators

• Rigel Pharmaceuticals: lead

Study Sites (65)

Divison of Rheumatology Allergy and Immunology

La Jolla, California, 92037, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Arthritis & Osteoporosis Center, PC

Hamden, Connecticut, 06518, United States

Location

Cynthia Morgan

Washington D.C., District of Columbia, 20003, United States

Location

Florida Medical Research Institute

Gainsville, Florida, 32607, United States

Location

Paddock Park Clinical Research

Ocala, Florida, 34474, United States

Location

Jeffrey Poiley, MD

Orlando, Florida, 32804, United States

Location

Lovelace Scientific Resources

Sarasota, Florida, 34233, United States

Location

Rheumatology Associates, SC

Chicago, Illinois, 60612, United States

Location

Memorial Medical Group Clinical Research Inst

South Bend, Indiana, 46601, United States

Location

Center for Arthritis & Osteoporosis

Elizabethtown, Kentucky, 42701, United States

Location

The Osteoporosis & Clinical Trials Center

Hagerstown, Maryland, 21740, United States

Location

Fiechtner Research, Inc.

Lansing, Michigan, 48910, United States

Location

Westroads Medical Group

Omaha, Nebraska, 68114, United States

Location

North Carolina Arthritis & Allergy Care Center

Raleigh, North Carolina, 27609, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Rheumatology Associates

Erie, Pennsylvania, 16508, United States

Location

Clinical Research Center of Reading, LLP

West Reading, Pennsylvania, 19611, United States

Location

Rheumatic Disease Associates

Willow Grove, Pennsylvania, 19090, United States

Location

Rheumatology Associates

Charleston, South Carolina, 29407, United States

Location

Austin Rheumatology & Research

Austin, Texas, 78705, United States

Location

Arthritis Center of South Texas

San Antonio, Texas, 78232, United States

Location

Arthritis Northwest, PLLC

Spokane, Washington, 99204, United States

Location

MNTranspH "Tsar Boris Treti"

Sofia, Gsof, Bulgaria

Location

MHAT "Kaspela"

Plovdiv, PLO, 4002, Bulgaria

Location

MHAT Ruse

Rousse, 7002, Bulgaria

Location

DCC "Sv. Anna" Sofia

Sofia, 1709, Bulgaria

Location

Unidad Medica Torre Plaza

Medellín, Antioquia, Colombia

Location

Centro de Reumatologia y Ortopedia

Barranquilla, Atlántico, Colombia

Location

Reumatologos del Caribe

Barranquilla, Atlántico, Colombia

Location

CIREEM

Bogota, Cundinamarca, Colombia

Location

Fundación Instituto de Reumatología

Bogota, Cundinamarca, Colombia

Location

Riesgo de Fractura S.A

Bogota, Cundinamarca, Colombia

Location

Private Office

Bogotá, Cundinamarca, Colombia

Location

Centro Medico Carlos Ardila Lulle

Bucaramanga, Santander Department, Colombia

Location

SERVIMED

Bucaramanga, Santander Department, Colombia

Location

Christus Muguerza del Parque

Chihuahua City, Chihuahua, 31000, Mexico

Location

Arké Estudios Clínicos S.A de C.V

México, D.f., 6700, Mexico

Location

Clínica para el Diagnostico y Tratamiento de

México, D.f., 6700, Mexico

Location

Hospital Ángeles Metropolitano

México, D.f., 6700, Mexico

Location

Hospital General de México

México, D.f., 6726, Mexico

Location

Hospital Aranda de la Parra

León, Guanajuato, 37000, Mexico

Location

Instituto Jalisciense de Investigación Clínica

Guadalajara, Jalisco, 44100, Mexico

Location

Hospital Civil de Guadalajara "Fray Antonio A

Guadalajara, Jalisco, 44280, Mexico

Location

Centro Médico DALINDE

Mexico City, Mexico City, 6760, Mexico

Location

Centro de Investigacion Clinical de Morelia

Morelia, Michoacán, Mexico

Location

Hospital Inovamed , Torre Médica

Cuernavaca, Morelos, 62270, Mexico

Location

NZOZ Centrum Medyczne Artur Racewicz

Bialystok, 15-337, Poland

Location

Szpit. Spec.Nr 1, Odz. Reumatol. i Reh.

Bytom, 41-902, Poland

Location

Wojewodzki Szpital Zespolony Oddzial Reumatol

Elblag, 82-300, Poland

Location

Mazowieckie Centrum Badan Klinicznych

Grodzisk Mazowiecki, Poland

Location

Malopolskie Centrum Medyczne SC

Krakow, 30-510, Poland

Location

Krakowskie Centrum Medyczne NZOZ

Krakow, 31-501, Poland

Location

NZOZ Reumed

Lublin, 20-607, Poland

Location

NZOZ "Nasz Lekarz"

Torun, 87-100, Poland

Location

Synexus SCM

Wroclaw, 50-088, Poland

Location

ASK Klinika Reumatologii i Chor. Wewn.

Wroclaw, 53-137, Poland

Location

ZOZ w Zyradowie Oddzial Reumatologii

Zyradow, 96-300, Poland

Location

Spitalul Clinic Judetean de Urgenta Cluj Reum

Cluj-Napoca, Cluj, 400006, Romania

Location

Spitalul Clinic "Sf. Maria" Med Int si Reumat

Bucharest, Sector 1, 11172, Romania

Location

Spitalul Clinic Judetean Sibiu

Sibiu, Sibiu County, 550245, Romania

Location

CMI "Cristei R. Dorica"

Brăila, 810219, Romania

Location

Spitalul de Urgenta al MAI Dr. D. Gerota

Bucharest, 021392, Romania

Location

Spitalul Judetean "Dr. Fogolyan Kristol"

Sf. Gheorghe, 520064, Romania

Location

Related Publications (1)

• 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.

  PMID: 20879879 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The 2 placebo groups (bid and qd) were pooled for all efficacy data summaries and analysis since the observed ACR20 response rate difference between the placebo groups was \<15 percentage points (prospectively defined in protocol).

Results Point of Contact

• Title: Anne-Marie Duliege, MD
• Organization: Rigel

clinicaltrials@rigel.com

650-624-1100

Study Officials

• Daniel B Magilavy, MD

  Rigel Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 16, 2016
• Results First Posted: June 13, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (9); US (24); PL (11); BU (4); RO (6); ME (11)