Updated October 09, 2014.

This article is part of the Arthritis Archives.

Editor note: Humira (adalimumab) was approved by the United States Food and Drug Administration on December 31, 2002

Dateline: October 15, 2002

Adalimumab: Abbott's Fully Human Anti-TNF Therapy

Abbott Laboratories has announced the initiation of a study which will make its investigational medication Humira (known as D2E7 or adalimumab) available to rheumatoid arthritis patients in need of additional treatment options.

Patients with moderately to severely active rheumatoid arthritis who have failed treatment with one or more traditional disease-modifying anti-rheumatic drugs (DMARDs) may be eligible to receive Humira (D2E7) as part of the study.

About The Program

In the United States, the program is known as Access To Therapy (ACT) In RA Study. Similar programs are being developed in Europe. The ACT study is designed to be an open-label, multi-center study. Study participants will receive D2E7 as a subcutaneous injection, with or without the continuation of other DMARDs. At specific intervals, patients will be assessed for improvement in the signs and symptoms of rheumatoid arthritis. Those patients demonstrating at least a 20 percent improvement will be allowed to remain in the study.

About Humira

Humira (D2E7) was developed as the first fully human monoclonal antibody for the treatment of rheumatoid arthritis. D2E7 works by blocking TNF-alpha (tumor necrosis factor alpha). Currently, D2E7 is under review by the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA).

The regulatory submissions to the FDA and EMEA are based on results from 23 clinical trials which involved 2,300 rheumatoid arthritis patients in North America, Europe, and Australia. Humira (D2E7) is also being evaluated in clinical trials for the treatment of juvenile rheumatoid arthritis (JRA) and Crohn's disease.

Patients Eligible

Patients eligible for inclusion in the ACT study must meet the following criteria:

• Must be 18 years old or older with active rheumatoid arthritis (have six or more swollen joints and nine or more tender joints).
• Patients must be diagnosed with rheumatoid arthritis according to American College of Rheumatology (ACR) criteria for at least 3 months.
• Patients must have had an unsatisfactory response or intolerance to one or more DMARDs.
• Patients must be categorized as functional class I, II, or III according to 1992 ACR criteria.
• If using prednisone, takes 10 mg. or less daily.
• Must be evaluated for latent tuberculosis, and if there is evidence of prior TB infection, patient should be given prophylaxis according to CDC guidelines. Prophylaxis must be started but need not be completed before adalimumab is administered. Patients having undergone prophylaxis treatment in the past need not repeat it.
• Childbearing-age women must test negative for pregnancy at the outset of the study and must use adequate contraception.

Patients Not Eligible

Patients would not be eligible for the ACT study if:

• Previously treated with cyclophosphamide or chlorambucil.
• Previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies, resulting in persistent CD4 lymphopenia.
• Previously treated with intravenous immunoglobulin or any investigational agent within 30 days or 5 half-lives of the product, whichever is longer.
• Patient has history of cancer within the last 10 years other than resected basal cell or squamous cell carcinomas of the skin.
• Patient has history of malignant lymphoma or leukemia.
• Patient has history of current acute inflammatory joint disease of origin other than rheumatoid arthritis (i.e. lupus, mixed connective tissue disease, etc.).
• Patient has history of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, stroke within last 3 months.
• Patient has history of active tuberculosis or listeriosis.
• Patient has positive serology for hepatitis B or C indicative of active infection.
• Patient with history of positive HIV status.
• Patients with persistent infection or severe infections requiring hospitalization or treatment with I.V. antibiotics within 30 days, or oral antibiotics within 14 days prior to study enrollment.

In the United States, patients and/or physicians interested in the ACT study can call 1-800-553-1618 for more information.

Related Resources

Humira (adalimumab)

TNF Blockers / Biologic DMARDs

TNF Blockers (Enbrel, Remicade, Humira) - Test Your Knowledge

Rheumatoid Arthritis

_{Sources: Abbott Laboratories Announces Study To Make D2E7 (Adalimumab) Available To Rheumatoid Arthritis Patients In Need, October 9, 2002, PRNEWSWIRE; ACT Access To Therapy, www.abbottimmunology.com
First published: 10/15/2002}