ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Inflammation Disrupts Memory - What Can You Do to Protect Your Brain?

Artificial sweeteners linked to risk of weight gain, heart disease and other health issues

All About Ginkgo Biloba: Benefits of This Timeless Herbal Supplement

Yarrow Oil: Here's Why It Deserves a Place in Your First-Aid Kit

Vitamin D supplement use associated with lower risk of breast cancer

Carnitine deficiency suggested as contributor to autism

Lutein — An Important Nutrient for Eye and Brain Health

Hop Oil: A Safe Sleep Aide

White Camphor Oil: The Purest Camphor Oil

Taurine: Facts About This Crucial Amino Acid

Print Page
Email Article

Drug News: Clinical Trials to Explore use of Adalimumab in Juvenile Rheumatoid Arthritis and Crohn’s Disease

  [ 39 votes ]   [ Discuss This Article ] • September 20, 2002

Abbott Laboratories has recently announced the expansion of its Immunology clinical trials program to include studies evaluating the potential of the first fully human monoclonal antibody, D2E7 (adalimumab), in juvenile rheumatoid arthritis (JRA) and Crohn's disease. JRA and Crohn's disease are autoimmune disorders in which a human protein, tumor necrosis factor-alpha (TNF-á), has been shown to cause abnormal immune responses. D2E7 is being studied in other inflammatory diseases because its mechanism of action specifically targets TNF-á.

D2E7 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) for the treatment of adult rheumatoid arthritis (RA).

Juvenile Rheumatoid Arthritis (JRA) Trial
D2E7 will be studied in a randomized, multicenter, double-blind Phase III clinical trial that will assess its safety and efficacy in patients with polyarticular juvenile rheumatoid arthritis (JRA). Patient responses will be measured by the American College of Rheumatology (ACR) Pediatric 30 score, which is a 30 percent improvement in JRA signs and symptoms such as the number of joints with active arthritis and loss of motion, assessment of pain and degree of disability.

"We've seen tremendous advances in the treatment of adult RA and studies in pediatric patients are critical to understanding the potential use of new treatments in children who are fighting destructive symptoms at a much younger age," said Daniel Lovell, M.D., M.P.H., chairman, Pediatric Rheumatology Study Group and professor of Pediatrics, Cincinnati Childrens Hospital Medical Center. "This disease can be particularly troubling for children because of its impact on their ability to participate in activities with other children. The symptoms of JRA are similar to adult RA, including swollen and tender joints that if untreated may affect a child's growth and development and lead to permanent joint destruction."

While the symptoms may be mild in some children, the disease can be persistent, ultimately damaging joints by eroding bones and cartilage. As the most common form of juvenile arthritis, JRA strikes children 16 years of age or younger, and affects girls twice as often as boys.

Crohn's Disease
A Phase II/III study has been initiated that will evaluate the safety and efficacy of D2E7 in the induction of clinical remission in subjects with Crohn's disease. Clinical remission refers to patients who are not showing any symptoms of the disease following treatment. Patients in the trial will be randomized to receive D2E7 or placebo and responses will be measured according to the Crohn's Disease Activity Index (CDAI) score. The CDAI is a commonly used tool that measures factors such as weight loss and abdominal pain.

"Crohn's disease is an immune disorder where patients experience sometimes severe gastrointestinal symptoms because of an inflammatory response in the intestinal tract," said Stephen Hanauer, M.D., professor and director, Gastroenterology Section, Department of Medicine, University of Chicago. "Currently, patients with Crohn's disease have limited treatment options to consider and this trial is designed to assess the effect of D2E7 in the treatment of these patients."

Crohn's disease is a serious inflammatory disease of the gastrointestinal (GI) tract, usually beginning in late childhood or early adulthood. Common symptoms include diarrhea, abdominal pain, weight loss, fever, and in some cases rectal bleeding.

About D2E7
D2E7 (adalimumab) is the first fully human monoclonal antibody to be developed. D2E7 works by specifically blocking the activity of tumor necrosis factor alpha (TNF-á), which plays a central role in the inflammatory responses of many autoimmune diseases. Regulatory submissions in the United States and Europe are based on data from 23 clinical trials in RA involving more than 2,300 patients in North America, Europe and Australia, making D2E7 the most-studied anti-TNF agent at the time of submission for regulatory approvals.

Monoclonal antibodies mimic naturally occurring antibodies and can recognize and neutralize proteins that play a role in promoting the inflammatory process associated with many autoimmune diseases. Fully human monoclonal antibodies have a protein structure that makes them essentially indistinguishable from antibodies present in the human body.

Post a Comment

Featured Products From the ProHealth Store
Ultra ATP+, Double Strength Vitamin D3 Extreme™ Optimized Curcumin Longvida®

Article Comments

Be the first to comment on this article!

Post a Comment

NAD+ Ignite with Niagen

Featured Products

Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health

Natural Remedies

Sunshine Vitamin Has D-lightful Health Benefits Sunshine Vitamin Has D-lightful Health Benefits
Repair Damaged Mitochondria and Reduce Fatigue Up to 45% Repair Damaged Mitochondria and Reduce Fatigue Up to 45%
Block food Cravings At Their Molecular Root Block food Cravings At Their Molecular Root
D-ficient? Health Risks You Need to Know About D-ficient? Health Risks You Need to Know About
The Guaifenesin Story: A centuries-old bark extract used for clearing the airways – now key to a popular FM symptom-reversal protocol The Guaifenesin Story: A centuries-old bark extract used for clearing the airways – now key to a popular FM symptom-reversal protocol

ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
Credit Card Processing
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map