Clinical Trial: A Study of Adalimumab to Treat Sarcoidosis of the Skin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of Adalimumab in the Treatment of Cutaneous Sarcoidosis

Brief Summary: The purpose of this study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis.

Detailed Summary: The cutaneous lesions of sarcoidosis are often disfiguring and can produce functional impairment. They tend to be hard to treat with most topical therapies and often require systemic medications which carry the risk of significant side effects. Often such treatments are withheld unless there is a need to use them for visceral involvement. There is thus an unmet need for safe and effective treatments for these patients. In addition there is essentially no controlled trial data for any treatments for cutaneous sarcoidosis. This study is intended to determine if adalimumab might offer a viable therapeutic option for this condition by comparing the response of cutaneous sarcoid lesions to this drug as compared to placebo.
Sponsor: Pariser, Robert J., M.D.

Current Primary Outcome: The proportion of subjects who are Responders, achieving at least Moderate Improvement on the Physician's Global Assessment, after 12 weeks of treatment during Period A (double-blind phase). [ Time Frame: at completion of double-blind phase (12 weeks) ]

Original Primary Outcome: The proportion of subjects who are Responders, achieving at least Moderate Improvement on the Physician's Global Assessment, after 12 weeks of treatment during Period A (double-blind phase).

Current Secondary Outcome:

  • Proportion of subjects achieving a PGA (Physician's Global Assessment) of Clear or Marked Improvement after 12 weeks of treatment during Period A. [ Time Frame: at completion of double-blind phase (12 weeks) ]
  • Proportion of subjects achieving at least a PGA of Mild Improvement after 12 weeks of treatment during Period A. [ Time Frame: at completion of double-blind phase (12 weeks) ]
  • Change in the patient's Quality of Life score relative to baseline after 12 weeks of treatment during Period A. [ Time Frame: at completion of double-blind phase (12 weeks) ]
  • Change in the Patient's Global Assessment relative to baseline after 12 weeks of treatment during Period A. [ Time Frame: at completion of double-blind phase (12 weeks) ]
  • Proportion of subjects with a 12% or greater improvement (minimum of 200mL change) in FVC and/or FEV1 after 12 weeks of treatment during Period A. (This is the minimum change thought to be clinically significant per American Thoracic Society Statement [ Time Frame: at completion of double-blind phase (12 weeks) ]
  • Proportion of subjects with improvement in pulmonary diffusing capacity after 12 weeks of treatment during Period A. [ Time Frame: at completion of double-blind phase (12 weeks) ]
  • Proportion of subjects with observed improvement on chest radiograph after 12 weeks of treatment during Period A. [ Time Frame: at completion of double-blind phase (12 weeks) ]
  • (Sub group analysis of all subjects by CXR stage at study entry will be performed for all respiratory variables) [ Time Frame: at completion of double-blind phase (12 weeks) ]
  • Change target lesion dimensions and estimated thickness. [ Time Frame: at completion of double-blind phase (12 weeks) ]


Original Secondary Outcome:

  • • Proportion of subjects achieving a PGA (Physician’s Global Assessment) of Clear or Marked Improvement after 12 weeks of treatment during Period A.
  • • Proportion of subjects achieving at least a PGA of Mild Improvement after 12 weeks of treatment during Period A.
  • • Change in the patient’s Quality of Life score relative to baseline after 12 weeks of treatment during Period A.
  • • Change in the Patient’s Global Assessment relative to baseline after 12 weeks of treatment during Period A.
  • • Proportion of subjects with a 12% or greater improvement (minimum of 200mL change) in FVC and/or FEV1 after 12 weeks of treatment during Period A. (This is the minimum change thought to be clinically significant per American Thoracic Society Statement
  • • Proportion of subjects with improvement in pulmonary diffusing capacity after 12 weeks of treatment during Period A.
  • • Proportion of subjects with observed improvement on chest radiograph after 12 weeks of treatment during Period A.
  • (Sub group analysis of all subjects by CXR stage at study entry will be performed for all respiratory variables)
  • • Change target lesion dimensions and estimated thickness.


Information By: Pariser, Robert J., M.D.

Dates:
Date Received: January 6, 2006
Date Started: September 2006
Date Completion:
Last Updated: May 20, 2013
Last Verified: May 2013