The Clinical Trials Unit at the Denver Arthritis Clinic is actively enrolling patients for studies of new agents in a variety of rheumatologic conditions. Dr. C. Ryan Antolini is the director of the trials unit and works closely with the study team.
Clinical research studies are conducted in carefully designed phases to ensure that new treatments are safe and effective before they become widely available. Each phase builds on the previous one.
Phase I — Safety and Dosage
Phase I studies are the first time a new treatment is tested in people.
Focus: Safety, side effects, and appropriate dosage
Participants: Small group (often 20–80 individuals)
Goal: Determine how the treatment behaves in the body and identify any potential risks
Phase II — Effectiveness and Side Effects
Once a treatment is shown to be safe, it moves into Phase II.
Focus: Effectiveness and continued safety evaluation
Participants: Larger group (typically 100–300 individuals)
Goal: Assess whether the treatment works for a specific condition and further evaluate side effects
Phase III — Comparison and Confirmation
Phase III studies involve a much larger population and are often required for regulatory approval.
Focus: Confirm effectiveness and monitor adverse reactions
Participants: Large groups (300–3,000+ individuals)
Goal: Compare the new treatment to current standard treatments and gather data for approval
Phase IV — Post-Approval Monitoring
After a treatment is approved and available to the public, Phase IV studies continue to track its performance.
Focus: Long-term safety and real-world effectiveness
Participants: Broad patient populations
Goal: Identify rare or long-term side effects and optimize use in everyday care
Why Clinical Research Matters
Clinical trials are essential to advancing medical care. They provide access to new therapies, contribute to scientific knowledge, and help improve outcomes for future patients.
At DAC, our clinical research program is committed to patient safety, scientific integrity, and expanding treatment options for those living with rheumatic diseases.
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