Clinical Trials

What is a Clinical Trial?

A clinical trial is a research study designed to investigate new drugs or devices to see if they work and if they are safe. All prescription medications available today have gone through clinical studies. Because of this research, we now have new, more effective treatments for hundreds of diseases. Clinical trial participants are critical to the development of novel and improved therapies for rheumatoid arthritis, osteoarthritis, and other autoimmune disorders.

What to expect

To determine if a new drug or therapy is safe and effective, some participants will be administered the study medication, while others will take a placebo (a sugar pill that contains no active medication). Those who decide to volunteer for a particular clinical study will be advised of the potential risks and benefits of participating when they review the informed consent with their physician or study coordinator.

Clinical studies are carefully monitored by a team of doctors and nurses, in addition to government health authorities and medical ethics groups. All information is kept confidential. Participation is completely voluntary throughout and you can stop at any time without affecting your care.

During participation in a clinical trial, it is important for patients to be able to reach their study physician and/or study coordinators at any time. As such, participants are given a 24-hour access phone number for questions regarding their medication, disease activity, or general health. Patients are asked to report all medical concerns that occur during the research study. Patients are usually required to keep all other significant medications stable during the course of the study and are encouraged to also maintain regular visits with their physician.

Patient Consent

Prior to entering into a clinical trial, a patient is required to discuss the details of the study with his or her physician and to complete an informed written consent form confirming their understanding of the parameters involved. This process usually outlines:

  • The purpose of the study
  • The type of medication being investigated and its general mechanism of action
  • Known potential risks and side effects of the study medication
  • Length of the study
  • Number of visits involved and what will occur at each
  • Results of previous investigations using the experimental approach
  • Description of the placebo arm
  • Type(s) of evaluation to be done
  • Limitations on access to medical records
  • Confidentiality requirements for investigators
  • Other treatment options available
  • The right to discontinue at any time

Screening Process

Prior to participating in a clinical trial, a patient is required to undergo a thorough screening process to ensure suitability for the study in question. During this process, the investigator conducts an examination of the patient's medical history, performs a physical examination and blood is drawn for laboratory testing. As well, in some cases, patients may be asked to complete a brief questionnaire regarding disease activity, previous treatments, quality of life, etc.

Inclusion Criteria

  • 18-75 years of age
  • Diagnosed rheumatoid disease according to defined criteria
  • Provision of informed written consent
  • All additional medications stable

Exclusion Criteria

  • Pregnant or breastfeeding women
  • Subjects with more than one distinct autoimmune disease
  • Patients with uncontrolled medical or surgical conditions that place the patient at an unacceptable risk for participation
  • Subjects with a history of malignant cancers
  • Clinically significant drug or alcohol abuse
  • Subjects with diagnosed Hepatitis or HIV

Benefits and Risks

Though every study is different, some of the significant benefits available for participating in a clinical trial include the following:

  • A chance to receive a new therapeutic that is not available to the general public
  • The opportunity to participate in breakthrough research that may aid the future understanding and care for others with your disorder
  • Knowledge that you are helping to advance medical science

Potential risks include the following:

  • Possible side effects from the study medication
  • In some studies you may receive a placebo (sugar pill) that contains no active medication
  • There are no guarantees the treatment will actually work