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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Rheumatic Heart Disease II: Clinical Manifestations and Diagnostic Studies01:22

Rheumatic Heart Disease II: Clinical Manifestations and Diagnostic Studies

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The key clinical manifestations of Rheumatic heart disease (RHD) include several distinct cardiac symptoms.Carditis, a hallmark of acute rheumatic fever, involves inflammation of the heart's endocardium, myocardium, and pericardium. Chronic RHD often results from recurrent episodes of carditis. Its symptoms include the following:Murmurs are caused by valvular damage, especially to the mitral and aortic valves. Mitral stenosis or regurgitation is common, with characteristic heart murmurs...
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Phase II Reactions: Glucuronidation01:24

Phase II Reactions: Glucuronidation

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Glucuronidation, a pivotal phase II biotransformation process, involves the coupling of glucuronic acid to a drug or xenobiotic. Given its widespread occurrence and critical role in drug metabolism, it's considered the most crucial phase II reaction. It enhances the water solubility of substances, aiding their expulsion from the body. The driving force behind these reactions is a group of enzymes known as UDP-glucuronosyltransferases (UGTs). UGTs facilitate the transfer of a glucuronic acid...
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Rheumatic Heart Disease III: Medical Management01:21

Rheumatic Heart Disease III: Medical Management

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Rheumatic heart disease (RHD) management can be divided into two main strategies: prevention and long-term management.Primary PreventionPrimary prevention focuses on timely diagnosis and management of group A streptococcal pharyngitis to prevent acute rheumatic fever. The most widely used antibiotic for treating this condition is intramuscular benzathine penicillin G.Acute Rheumatic Fever TreatmentThe primary treatment goal for a patient diagnosed with acute rheumatic fever is to suppress the...
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Rheumatic Heart Disease I: Introduction01:23

Rheumatic Heart Disease I: Introduction

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Rheumatic heart disease or RHD is a chronic condition that results from rheumatic fever, causing permanent damage to the heart valves.Etiology and Risk FactorsIt primarily arises from rheumatic fever, an inflammatory disease that can develop after untreated or inadequately treated group A streptococcal (GAS) pharyngitis. Streptococcus spreads through direct contact with oral or respiratory secretions. While the bacteria are the causative agents, factors like malnutrition, overcrowding, poor...
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A Phase 2 Trial of Hydroxychloroquine in Individuals at Risk for Rheumatoid Arthritis.

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Area of Science:

  • Rheumatology
  • Immunology
  • Clinical Trials

Background:

  • Individuals with elevated anti-cyclic citrullinated peptide (anti-CCP) antibodies face a higher risk of developing rheumatoid arthritis (RA).
  • No approved pharmacologic treatments exist for preventing RA in this at-risk population.
  • Hydroxychloroquine (HCQ) is sometimes used off-label for RA prevention without robust clinical trial data.

Purpose of the Study:

  • To evaluate the efficacy of hydroxychloroquine (HCQ) in preventing the development of clinical rheumatoid arthritis (RA) in at-risk individuals.
  • To assess the safety and tolerability of HCQ in this population.

Main Methods:

  • A phase 2 randomized trial involving individuals with anti-CCP levels at least twice the upper limit of normal (ULN).
  • Participants received either HCQ or placebo for 12 months, with follow-up up to 36 months.
  • Primary outcome was the development of clinical RA; secondary outcomes included inflammatory arthritis and participant-reported symptoms.

Main Results:

  • Clinical RA developed in 30.4% of the HCQ group versus 32.9% of the placebo group (P=0.52).
  • No significant differences were observed in the risk of clinical RA, inflammatory arthritis, or joint symptoms between the groups.
  • Adverse event incidence and severity were similar across both treatment arms.

Conclusions:

  • Twelve months of hydroxychloroquine (HCQ) treatment did not prevent the development of clinical rheumatoid arthritis (RA) in individuals with elevated anti-CCP antibodies.
  • The study did not support the use of HCQ for RA prevention in this at-risk group.