Clinical Trials

Changing the course of human health through bold pursuits in science

As the needs of patients worldwide evolve, Celgene remains dedicated to meeting those needs. Our mission is to use our research to reach those around the globe who experience serious and life-threatening diseases. Clinical trials are a critical part of our research and development pipeline, ensuring that the life-saving treatments that reach patients are both safe and effective. Our research and development team works in collaboration with our patient safety team to ensure that patients who participate are involved in safe, well-planned studies.
 
Celgene-sponsored Clinical Trials
Celgene currently sponsors more than 100 clinical trials examining at least 25 unique compounds. Approximately 28,000 patients are actively enrolled in Celgene-sponsored clinical trials, for more than 50 different indications. The corresponding treatments are aimed at addressing the unmet needs of 25 million people worldwide in more than 30 disease areas.
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Investigator-initiated Clinical Trials
In addition, we support more than 500 investigator-initiated trials that use approved therapies or investigational compounds from Celgene.
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Expanded Access

About Expanded Access at Celgene

At Celgene, we believe that wherever possible, use of an investigational medicine for a patient as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability.    We encourage patients to speak with their physicians about eligibility to enroll in any of Celgene’s clinical trials. Learn more about Celgene clinical trial programs.

However, when patients with a serious or life threatening unmet medical need are unable to access our investigational products through a clinical trial and have exhausted all other therapies, Celgene may be able to provide access through its expanded access program.
 
Evaluation Criteria

In determining whether access is appropriate outside of a clinical trial, the criteria we evaluate include:

  • The disease is serious or life threatening
  • There are no beneficial available alternative treatments or patients have exhausted all other therapies
  • A clinical study is not available, either because patients are ineligible or because they have no access to the trial
  • The efficacy and safety data available at the time are of sufficient strength to determine whether the benefit to patient would likely outweigh the potential risks
  • Access is compliant with local rules and laws

 
Process for Requesting Access

Treating physicians may request information on PAA Programs and Single Patient Access by contacting Celgene’s Medical Information Department at 1-888-771-0141 or 1-908-673-9800 or by completing the online request form.  Celgene strives to respond to expanded access requests as quickly as possible, usually acknowledging receipt of a request within 24 hours.

If you are a patient with questions concerning access to our investigational products, either through a clinical trial or through expanded access, please consult with your treating physician.