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Home > "A" Clinical Trials Conditions > A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects with Active Rheumatoid Arthritis

A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects with Active Rheumatoid Arthritis



A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects with Active Rheumatoid Arthritis

For Condition: Rheumatoid Arthritis
Status: Recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: Purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior DMARDs.
Details:
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - Subjects must meet ACR criteria for diagnosis of RA for at least 3 months, must meet ACR Functional Class I, II or III (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints; - must also have DAS of 3.2 or greater at study entry, - normal laboratory parameters and ESR >20, - satisfactory response or intolerance to one or more prior DMARDs and - be willing and able to give informed consent. Exclusion: - Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia, - history of acute inflammatory joint disease other than RA, - prior treatment with cyclophosphamide or chlorambucil, - prior treatment with intravenous immunoglobulin within 70 days, - history of malignant lymphoma, - history of uncontrolled diabetes, - unstable ischemic heart disease, - active inflammatory bowel disease, - active peptic ulcer disease or stroke, - positive HIV status, - positive serology for Hepatitis B or C, - no previous history of tuberculosis or listeria infection, - no previous history of cancer other than successfully treated skin cancer; - women can not be pregnant or be breastfeeding
Total Enrollment: 

Location and Contact Information:

Intermountain Orthopedics *Recruiting*
Boise,  Idaho, 
United States
Recruiting Stacie  Rotzien 208-489-4350

Mike Schweitz, MD *Recruiting*
West Palm Beach,  Florida, 
United States
Recruiting Mike  Schweitz 561-659-4985

Rheumatology Associates, Ltd. *Recruiting*
Sellersville,  Pennsylvania, 
United States
Recruiting Linda  Kolb 215-257-5466

Kenneth Hsu, MD, Inc. *Recruiting*
Bakersfield,  California, 
United States
Recruiting Amy  Hsu 661-322-2329

Rockford Clinic, Clinical Research Department *Recruiting*
Rockton,  Illinois, 
United States
Recruiting Kathy  Lemonds-Johnson 815-971-2416

OSF Medical Group -Rheumatology *Recruiting*
Peoria,  Illinois, 
United States
Recruiting Mark  Getz 309-655-7900

Lewis-Gale Clinic *Recruiting*
Salem,  Virginia, 
United States
Recruiting Garry  Bayliss 540-772-5920

West Suburban Health Care *Recruiting*
Oak Park,  Illinois, 
United States
Recruiting Mary  Zoller 708-763-2536

Rheumatology Associates *Recruiting*
Norristown,  Pennsylvania, 
United States
Recruiting Mary  Carfagno 610-277-2750

Fallon Clinic Research *Recruiting*
West Boylston,  Massachusetts, 
United States
Recruiting Candace  LeBlanc 508-835-2960

Norman Gaylis, MD *Recruiting*
Aventura,  Florida, 
United States
Recruiting Joanne  Sagliani 305-652-6676

Arthritis and Osteoporosis Clinical Research Center of Central Texas *Recruiting*
Waco,  Texas, 
United States
Recruiting Liz  Flynn 354-755-4582

Division of Rheumatic Diseases/University of CT Health Center *Recruiting*
Farmington,  Connecticut, 
United States
Recruiting Fran  Ingenito 203-235-6402

Northampton Internal Medicine Association *Recruiting*
Northampton,  Massachusetts, 
United States
Recruiting Judy  Leeds 413-584-9511

NYU Hospital for Joint Disease *Recruiting*
New York City,  New York, 
United States
Recruiting Eileen  McCullagh 646-386-9400

Rheumatology Clinic *Recruiting*
Los Angeles,  California, 
United States
Recruiting Brian  Huh 213-483-4997

Margaret Gradzka, MD *Recruiting*
Fairfax,  Virginia, 
United States
Recruiting Margaret  Gradzka 703-684-9800

NJ Associates in Medicine *Recruiting*
Fairlawn,  New Jersey, 
United States
Recruiting Joanne  Emmolo 201-796-2255

Frederick Murphy, MD *Recruiting*
Duncansville,  Pennsylvania, 
United States
Recruiting Frederick  Murphy 814-693-0300

John Howland, MD *Recruiting*
Bay City,  Michigan, 
United States
Recruiting Amie  Glumm 989-892-1231

Medical Specialists of Nashville *Recruiting*
Nashville,  Tennessee, 
United States
Recruiting David  Knapp 615-340-4611

Desert Valley Medical *Recruiting*
Apple Valley,  California, 
United States
Recruiting Galene  Bell 760-241-8000

MedCenter One Health Systems *Recruiting*
Bismark,  North Dakota, 
United States
Recruiting Lynne  Peterson 701-323-6140

Sanford and Roumm Rheumatology *Recruiting*
Camp Hill,  Pennsylvania, 
United States
Recruiting Alan  Roumm 717-761-3505

Thomas McGee, MD *Recruiting*
Mobile,  Alabama, 
United States
Recruiting Thomas  McGee 251-435-1200

Loyola University Medical Center *Recruiting*
Maywood,  Illinois, 
United States
Recruiting Christine  McGee 708-216-6225

Metropolitan Clinical Research *Recruiting*
Falls Church,  Virginia, 
United States
Recruiting Marie  Rosario 703-533-3117

Freeman Health Systems *Recruiting*
Joplin,  Missouri, 
United States
Recruiting Shirley  Aldridge 417-206-9490

Mountain Rheumatology *Recruiting*
Denver,  Colorado, 
United States
Recruiting Pat  Graves 303-863-0300

New Haven Medical Group, PC *Recruiting*
New Haven,  Connecticut, 
United States
Recruiting Linda  Sabino 203-772-0011

Placido Morano, MD *Recruiting*
Brooklyn,  New York, 
United States
Recruiting Placido  Morano 718-743-9642

Alan Kaell, MD *Recruiting*
Port Jefferson,  New York, 
United States
Recruiting Alan  Kaell 631-928-4885

Institute of Arthritis Research *Recruiting*
Idaho Falls,  Idaho, 
United States
Recruiting Krysti  Pettingil 208-535-4379

Carolina Bone and Joint, PA *Recruiting*
Monroe,  North Carolina, 
United States
Recruiting Amy  Helms 704-289-4595

STAT Research, Inc. *Recruiting*
Dayton,  Ohio, 
United States
Recruiting Sanford  Wolfe

Rheumatology Associates *Recruiting*
Portland,  Maine, 
United States
Recruiting Ellen  Emerson 207-774-5761

Northern Virginia Center for Arthritis *Recruiting*
Reston,  Virginia, 
United States
Recruiting Karen  Almquist 703-709-9174

Midori Jane Nishio, MD *Recruiting*
Walnut Creek,  California, 
United States
Recruiting Midori  Nishio 925-280-9400

Internal Medicine and Rheumatic Diseases *Recruiting*
Millburn,  New Jersey, 
United States
Recruiting Lonnie  Hanoauer 973-376-2546

Arthritis and Osteoporosis Clinic, LLC *Recruiting*
Bend,  Oregon, 
United States
Recruiting Denise  Duncan-Rose 541-317-1812

Intermountain Orthopedics *Recruiting*
Boise,  Idaho, 
United States
Recruiting Stacie  Rotzien 208-489-4350

University Hospital of Cleveland *Recruiting*
Beachwood,  Ohio, 
United States
Recruiting Michele  Hooper 216-844-6007

Thomas Pressly, MD *Recruiting*
Shreveport,  Louisiana, 
United States
Recruiting Thomas  Pressly 318-635-5682

Michael Harrington, MD *Recruiting*
Napa,  California, 
United States
Recruiting Michael  Harrington 707-252-1035

Maurice McCarthy, MD *Recruiting*
Winter Haven,  Florida, 
United States
Recruiting Maurice  McCarthy 863-294-0670

Naveen Raja, MD *Recruiting*
Whittier,  California, 
United States
Recruiting Naveen  Raja 562-945-7252

Gordon Senter, MD Rheumatology, PA *Recruiting*
Salisbury,  North Carolina, 
United States
Recruiting Gina  Wright 704-633-9999

Center of Arthritis and Rheumatic Disease, PC *Recruiting*
Chesapeake,  Virginia, 
United States
Recruiting Connie  Dowell 757-547-2074

Arthritis Clinic *Recruiting*
Canton,  Ohio, 
United States
Recruiting David  Martin 330-492-4996

Pain Therapy Center *Recruiting*
Schaumburg,  Illinois, 
United States
Recruiting Veena  Nayak 847-352-5511

Peggy Schlesinger, MD *Recruiting*
Missoula,  Montana, 
United States
Recruiting Peggy  Schlesinger 406-490-7653

Jel M. Depper, MD *Recruiting*
Bend,  Oregon, 
United States
Recruiting Jel  Depper 541-317-1700

Low Country Research Center *Recruiting*
N. Charleston,  South Carolina, 
United States
Recruiting Pam  Risden 843-797-8585

John Howland, MD *Recruiting*
Bay City,  Michigan, 
United States
Recruiting Amie  Glumm 989-892-1231

ROAD Clinic *Recruiting*
Lakewood,  Washington, 
United States
Recruiting Pat  Williamson 253-983-8285

Baton Rouge Clinic *Recruiting*
Baton Rouge,  Louisiana, 
United States
Recruiting Shelley  Bourgois 225-769-4044


Additional Information:
Study ID Numbers:
  M02-498; 
Study Start Date: 
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049751

Other Rheumatoid Arthritis Studies:
1. Efficacy & Safety of an Investigational Drug + Methotrexate Compared to Methotrexate Alone in Patients with Rheumatoid Arthritis

2. Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis

3. Treating Rheumatoid Arthritis with Tripterygium Wilfordi Hook F or Sulfasalazine

4. Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions

5. Infliximab for the Treatment of Early Rheumatoid Arthritis

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