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

On-and-off fasting helps fight obesity, study finds

Can Pomegranates Slow Aging?

Calorie restriction promotes longevity through effects on mitochondrial network

Eat Your Prunes

Discover Why Ashwagandha Can Be Used for Stress and Anxiety

Lower magnesium levels linked with increased mortality risk during up to 40 years of follow-up

A spoonful of oil: Fats and oils help to unlock full nutritional benefits of veggies, study suggests

Higher resveratrol dose linked to lower glucose levels in type 2 diabetics

How Can You Benefit From Vitamin B12?

Drug can dramatically reduce weight of people with obesity

 
Print Page
Email Article

New Rheumatoid Arthritis Drug Begins Phase IIb Clinical Trials

  [ 17 votes ]   [ Discuss This Article ]
www.ProHealth.com • January 30, 2002




A new rheumatoid arthritis drug 5G1.1 will soon be entering a Phase IIb clinical trial designed to assess the safety and efficacy of the drug and to determine the most effective dose regimen.

This double-blind, randomized, placebo-controlled Phase IIb trial is expected to enroll 300 patients with mild to moderate rheumatoid arthritis and who are undergoing treatment with moderate doses of methotrexate or leflunomide.

"The commencement of this first 5G1.1 Phase IIb trial is an important step in the development of this promising drug candidate," stated Leonard Bell, M.D., President and Chief Executive Officer of the drug’s manufacturer Alexion. "We seek to confirm the promising clinical data obtained in our earlier 5G1.1 rheumatoid arthritis study in this larger patient study. Importantly, we also seek to build on the durability of response observed in the previous study, which evaluated patients after three months of treatment."

The trial will consist of three different treatment options. Patients will be treated with placebo; 5G1.1 at 8 mg/kg intravenous injection once per week for four weeks and then once every month, or 5G1.1 at 8 mg/kg intravenous injection once per week for four weeks, and then once every two weeks.

The patients will be evaluated after six months for safety and efficacy. The primary efficacy endpoint will be the ACR20 score. The ACR20 score indicates that a patient had a 20% improvement in tender and swollen joint count plus 20% improvement in at least 3 of 5 of the following criteria: patient pain assessment, physician global assessment, patient global assessment, patient self-assessed disability and acute phase reactant.

As presented at the American College of Rheumatology scientific meetings in November 2001, in an earlier Phase II trial with 209 patients, 5G1.1 administration appeared to be safe and well tolerated.

The results after the three months of treatment showed that the Induction/monthly group met the primary endpoint of the trial, improvement in ACR20 score after three months of treatment, while the Induction/biweekly and Biweekly groups did not statistically meet the endpoint.

The kinds of adverse events found were comparable to placebo, and the most common adverse events were nausea and diarrhea.



Post a Comment

Featured Products From the ProHealth Store
FibroSleep™ Ultra ATP+, Double Strength Mitochondria Ignite™ with NT Factor®


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Supercharge Your Brain with Two Powerful Nutrients Supercharge Your Brain with Two Powerful Nutrients
Fatigue & Fibro Fog: Could You Have a B-12 Deficiency? Fatigue & Fibro Fog: Could You Have a B-12 Deficiency?
Stop Bacteria With Nature's Antibiotics Stop Bacteria With Nature's Antibiotics
Coenzyme Q10 - The Energy Maker Coenzyme Q10 - The Energy Maker
SAD? Coping with Seasonal Affective Disorder SAD? Coping with Seasonal Affective Disorder

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

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
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