This study will evaluate whether adrenocorticotropic hormone (ACTH) gel can decrease disease symptoms in patients with rheumatoid arthritis that is uncontrolled by other medications. The success of this treatment will be measured by changes in disease activity (number of affected joints) after 12 weeks of treatment. This study is being conducted in Pittsburgh, Pennsylvania.
The details
Treatment for rheumatoid arthritis (an auto-immune disorder in which the immune system starts attacking healthy joint tissue) focuses on achieving disease remission, or disease inactivity. For some patients this means trying many different treatments before the most effective is found, including non-steroidal anti-inflammatory drugs (Aleve, for example), methotrexate (Trexall), which decrease the immune response, or corticosteroids (Prednisone), which decrease inflammation.
However, some patients still experience symptoms such as joint pain and swelling despite treatment. Adrenocorticotropic hormone (ACTH) gel can stimulate the body to produce its own steroid hormones, which can act as anti-inflammatory agents.
This trial will examine the use of ACTH gel in patients experiencing symptoms despite ongoing treatment. The success of ACTH gel will be measured by improvement of symptoms and a decrease of disease activity (such as number of joints affected).
Who are they looking for?
This study will recruit 20 patients with a rheumatoid arthritis diagnosis and current active disease. Patients must have been treated with a biologic agent (a drug that inhibits the immune system) for 6 months, and must be on stable doses of any rheumatoid arthritis medication for at least 4 weeks prior to study entry.
Patients will be excluded if they have an active infection requiring antibiotics, uncontrolled hypertension (high blood pressure), or abnormal kidney or liver function. Women must not be pregnant.
How will it work
Each participant will receive 1mL of ACTH gel subcutaneously (injected under the skin) twice a week for 12 weeks, in addition to their current treatment regimen. At the end of 12 weeks, participants will be evaluated for improvements in symptom severity, changes in disease activity (number of affected joints), and level of fatigue.
