Efficacy Study of Humira in the Treatment of Cutaneous Sarcoidosis
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II, Multi-Center, Open Label Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis|
- Change in Physician Global Assessment score from baseline to Week 24. [ Time Frame: week 0 and week 24. ]
- Change in Physician Target Lesion Assessment score from baseline to Week 24. [ Time Frame: Week 0 and week 24. ]
- Number of complete responders, partial responders, minimal responders, and non-responders at Week 24. [ Time Frame: Week 0, week 1, week 4 and then every 4 weeks until week 24. ]
- Mean change in Body Surface Area by visit. [ Time Frame: Week 0, week 1, week 4 and then every 4 weeks until week 24. ]
- Change in Physician Global Assessment score by visit. [ Time Frame: Week 0, week 1, week 4 and then every 4 weeks until week 24. ]
- Change in Physician Target Lesion Assessment score by visit. [ Time Frame: Week 0, week 1, week 4 and then every 4 weeks until week 24. ]
- Mean change in the subject's evaluation of severity as measured by a 100 millimeter visual analogue scale by visit. [ Time Frame: Week 0, week 1, week 4 and then every 4 weeks until week 24. ]
- Change in dose of antibiotics and immunosuppressives used to treat sarcoid. [ Time Frame: Week 0, week 1, week 4 and then every 4 weeks until week 24. ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Patients being treated with Humira.
80 mg at week 0, then 40 mg weekly from week 1-week 23.
Sarcoidosis is a multisystem disease. Cutaneous involvement occurs in approximately 25% of patients with lesion morphologies varying widely. There is no universally accepted treatment for sarcoidosis. Systemic agents such as oral corticosteroids are frequently necessary for treatment, but long-term therapy is limited by a multitude of serious adverse effects. Steroid-sparing agents such as methotrexate, azathioprine, anti-malarials, pentoxifylline, allopurinol, and thalidomide have been shown beneficial for select patients, but are limited due to significant toxicities of their own or inconsistencies in efficacy.
Infliximab is a chimeric, monoclonal antibody directed against TNF-α and is currently approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding domain of the human TNF receptor linked to the Fc portion of human IgG1. Etanercept has been approved for the treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. Treatment with infliximab and etanercept was generally well tolerated and safe in these reports.
To date, there have been no reports describing the treatment of sarcoidosis with adalimumab. Adalimumab (Humira; Abbott Laboratories, Abbot Park, IL) is a fully human, monoclonal antibody directed against TNF-α and is approved by the US FDA to treat rheumatoid arthritis. Given that adalimumab targets the same cytokine as infliximab and etanercept, one would expect that adalimumab may also be effective in the treatment of sarcoidosis. Treatment with adalimumab is advantageous over infliximab through differences in drug delivery. Infliximab is delivered intravenously in the office. This requires routine office visits and vital sign monitoring by a health care professional.
Adalimumab, on the other hand, is administered subcutaneously once weekly or every other week by the patient at home. Patients can be instructed on proper injection technique during one nurse visit. Additionally, because adalimumab is fully human, patients may be less likely to form antibodies against the medication. Because of the lack of alternative safe, effective treatment for sarcoidosis, a clinical trial to evaluate the efficacy of adalimumab in the treatment of sarcoidosis is warranted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731757
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Michael P Heffernan, MD||Wright State University|