Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

Abbott

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00049751

M02-498

Details and patient eligibility

About

The 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 disease-modifying antirheumatic drugs (DMARDs).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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