Clinical Research Trials

Up Coming Trials:

ACT-STAR:
An open-label, randomized study to evaluate the safety, tolerability and efficacy of Actemra (Tocilizumab - TCZ) monotherapy or TCZ in combination with non-biologic DMARD’s in patients with moderate to severe active Rheumatoid Arthritis who have had an inadequate response to current non-biologic or biologic (disease modifying antirheumatic drugs) DMARD’s

Sponsor: 
Roche Laboratories, Inc.
Clinical Phase 3b

Indication: 
Rheumatoid Arthritis

Trial Design: 
Phase 3b, open-label, randomized, multicenter study in the United States.

Number of Subjects: 
Approximately 750

Target Population: 
Men and women >18 years of age, body weight <150kg, with moderate to severe RA currently experiencing inadequate clinical response, safety or tolerability related issues to a stable dose of non-biologic or biologic DMARD therapy.

Length of Study: 
24 week treatment period with a follow up 4 weeks after the end of the treatment period

Product: 
Actemra (Tocilizumab) 4 or 8 mg/kg is given as an intravenous (IV) infusion every 4 weeks for a total of 6 infusions. Only the TCZ 8 mg/kg dose will be permitted as monotherapy.

How Does This Medication Work:

IL-6 is a common protein found in all joints in the body and is a natural substance that can raise inflammation. Everyone has IL-6 in their body, but people with RA may have too much. Actemra inhibits the interleukin-6 receptor, thereby blocking interleukin-6.

Side Effects: 
Serious adverse events reported in Actemra global clinical studies include:

• Serious infections.
• Rare events of gastrointestinal perforation have been reported.
• Increases in liver function tests (ALT and AST) were seen in some patients.
  • These increases were generally mild and reversible, with no hepatic injuries.
• Increases in total cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and less commonly triglycerides have been seen.
• Hypersensitivity (allergic) reactions including a few cases of anaphylaxis.

Most common adverse events reported in clinical studies were:

• Upper respiratory tract infection
• Nasopharyngitis
• Headache
• Hypertension

If you are interested in knowing if you may be eligible to participate in a clinical research trial, please call our office.