Examples of clinical trials


Patient-Centered Clinical Trials

Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE)

The ADAPTABLE trial is currently in progress. It is a three-year clinical trial involving heart disease patients across the U.S. to discover which of two aspirin doses is best for patients who have heart disease. It makes use of the National Patient-Centered Clinical Research Network (PCORnet) to recruit and enroll patients. It was the first study to harness PCORnet to achieve a large sample size and reduce study costs.
Key Information:

  • ADAPTABLE aims to uncover the risks and benefits of each of two common dosages of aspirin (81 mg versus 325 mg) to prevent heart disease
    • What dose is best depending on age, health, and other circumstances?
    • What dosage reduces risk of heart attack or stroke?
    • For more information, click here. [http://theaspirinstudy.org/]

Bariatric Surgery

Bariatrics is the branch of medicine that deals with the causes, prevention, and treatment of obesity. This is a five-year clinical trial of 60,000 bariatric surgery patients enrolled from PCORnet to see the risks and benefits of the 3 most common bariatric procedures. The study also asked patients their opinions about:

  • whether to have bariatric surgery or not
  • what procedure is most recommended
  • follow-up care after surgery

Arthritis-Specific Clinical Trials

Safety Trial of Adalimumab in Rheumatoid Arthritis (STAR)

This study set out to evaluate the efficacy and safety of the drug adalimumab (Humira) given in combination with standard anti-rheumatic therapies such as conventional disease modifying anti-rheumatic drugs (DMARDs, such as methotrexate) and nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen) in patients with active rheumatoid arthritis that were not adequately responding to such standard therapies.

Key Information

  • Patients were randomly assigned to a placebo or to the treatment of 40 mg of adalimumab every other week and both groups continued their standard therapy.
  • It was a double-blind study, meaning neither patients nor researchers knew if the patient was receiving treatment or a placebo.
  • Patients and their symptoms were tracked over the course of 24 weeks.

Conclusion:

  • 40 mg of adalimumab every other week is effective and safe in combination with standard anti-rheumatic therapies.

Comparison of combination therapy with single-drug therapy in early rheumatoid arthritis: a randomized trial

The study was a two-year trial where patients were randomized to receive either a combination therapy (sulphasalazine, methotrexate, hydroxychloroquine, and prednisolone) OR a single drug therapy (DMARD with or without prednisolone).
Conclusion:

  • The combination therapy seemed to increase the efficacy of treatment in early rheumatoid arthritis patients.
  • It was also determined that it was better and not more hazardous than the single treatment therapy.

The Research on Actemra Determining Efficacy After Anti-TNF Failures Trial (RADIATE)

This study was a Phase III, randomized, double-blind, placebo controlled, parallel group study that aimed to find out whether tocilizumab (Actemra) and methotrexate was an effective treatment for RA patients whose disease had not improve when taking an anti-tumor necrosis factor (anti-TNF) medication. The trial was conducted throughout Australia, North America, Western Europe, and Latin America.

Conclusion:

  • The study demonstrated that tocilizumab (TCZ) and methotrexate is effective in patients who did not have a response to anti-TNF agents.
  • Patients responded to this treatment regardless of the number of failed treatments they had had with anti-TNF agents.

The Tocilizumab in Combination With Traditional DMARD Therapy (TOWARD)

The TOWARD study followed more than 1,000 moderate-to-severe RA patients across the U.S., Asia, and Latin America to study the efficacy of tocilizumab (TCZ) taken every 4 weeks in combination with DMARDs. The treatment group was compared to a control group that received only DMARDs.

Conclusion:

  • The study found that RA remission was achieved to a greater extent in the TCZ treatment group than the control group.

Opportunities to participate in clinical trials

If you are interested in being part of a clinical trial, there may be opportunities to learn more and get involved. The National Institutes of Health (NIH) maintains a website where you can look for opportunities. ClinicalTrials.gov is a database of privately and publicly funded clinical studies that are being conducted around the world. You can find studies that might be relevant for you by searching by disease and country.

For example, two trials in rheumatoid arthritis (RA) are currently being conducted in the US that do not involve testing a new drug: StopRA and TARGET.

StopRA

StopRA is a research study whose goal is to prevent RA in people who don’t yet have RA, but who are at risk for future RA because of an elevated blood test called CCP. Since RA runs in families we are interested in talking with you and your family more about participating in StopRA and getting tested for CCP. For more information, go to ClinicalTrials.gov or contact StopRA study coordinator Marie Feser at (303) 724-7510 or [email protected].

Treatments Against RA and Effect on FDG PET-CT:

The TARGET Trial

Did you know that rheumatoid arthritis patients have an increased risk of heart attacks and strokes? Could your arthritis medications lower this risk?

The study aims to compare the effect of two different RA treatments on cardiovascular health in patients who are considering a treatment change. The study is recruiting patients who are only taking methotrexate but in whom additional treatment will be added due to a lack of improvement. The trial will randomize participants to take a TNF inhibitor (Enbrel or Humira) in addition to their Methotrexate or to take Triple Therapy (Methotrexate + Sulfasalazine + Hydroxychloroquine). The study will provide you with all trial medications (excluding Methotrexate) for the 6-month duration of the study. Study involvement requires two FDG-PET/CT scans and six follow-up visits over a period of six months.
Eligibility
To participate in the study, you must:

  • Be 45 years or older (men) or 50 years or older (women)
  • Have a diagnosis of rheumatoid arthritis (RA) with moderate disease activity
  • Have taken methotrexate alone for two months and be considering a treatment change

Patients with a prior use of rituximab or with a history of cardiovascular disease are excluded.
Contact
More information is available at www.targetra.org. Interested patients can call the TARGET Central Number at (617)525-7830 or email TARGET Study Coordinator Rachel Broderick at [email protected].