EDU: Drugs - Golimumab

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http://www.clinicaltrial.gov/ct/show/NCT00265096?order=3 This drug is

currently in Phase III of Clinical Research study. Here are details about the

different phases followed by information on the drug.

Study Phase Most clinical trials are designated as phase I, II, or III, based

on the type of questions that study is seeking to answer:

In Phase I clinical trials, researchers test a new drug or treatment in a

small group of people (20-80) for the first time to evaluate its safety,

determine a safe dosage range, and identify side effects.

In Phase II clinical trials, the study drug or treatment is given to a larger

group of people (100-300) to see if it is effective and to further evaluate its

safety.

In Phase III studies, the study drug or treatment is given to large groups of

people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare

it to commonly used treatments, and collect information that will allow the drug

or treatment to be used safely.

These phases are defined by the Food and Drug Administration in the Code of

Federal Regulations.

You can find more on Clinical Trials at ClinicalTrials.gov

INFORMATION ON THE DRUG GOLIMUMAB:

American College of Rheumatology - Annual Scientific Meeting - 2005

http://www.thedoctorslounge.net/rheumatology/conferences/acr-2005/ra_golimumab.h\

tm

Golimumab (CNTO 148) shows clinical benefit in active rheumatoid arthritis

12/11/05 - 17/11/05, San Diego, USA

Results from a Phase 2 rheumatoid arthritis (RA) study assessing the safety

and efficacy of golimumab (CNTO 148), a fully-human anti-TNF-alpha therapy,

showed that it achieved the primary endpoint of the study. In this dose-ranging

trial, more than 60 percent of patients with moderately to severely active RA

treated with golimumab and methotrexate (MTX) experienced at least 20 percent

improvement in arthritis symptoms at week 16. Additionally, one-quarter of

patients receiving golimumab and MTX achieved remission as evaluated by Disease

Activity Score 28 (DAS28). These findings will be presented this week at the

American College of Rheumatology 2005 Annual Scientific Meeting.

" When treating a debilitating disease like RA, it is important to have several

treatment options, and we are encouraged by the safety and efficacy data we have

seen thus far for golimumab, " said Kay, MD, Director, Clinical Trials,

Rheumatology Unit, Massachusetts General Hospital, Associate Clinical Professor

of Medicine, Harvard University School of Medicine and lead study investigator.

Golimumab, developed by Centocor, Inc. and Schering-Plough, is a fully-human

anti-TNF-alpha IgG1 monoclonal antibody that targets and neutralizes both the

soluble and the membrane-bound form of TNF-alpha. Golimumab is currently being

investigated for administration by either subcutaneous (SC) injection or

intravenous (IV) infusion.

Data from the study showed that significantly more patients in all groups

receiving SC injections of golimumab plus MTX achieved ACR 50 response (marked

improvement in arthritis symptoms according to the American College of

Rheumatology scoring criteria) versus patients receiving placebo plus MTX.

Adults with active RA for at least three months' duration despite MTX therapy

were randomized to one of five treatment groups: placebo every two weeks or

golimumab 50 or 100 mg every two weeks or every four weeks. All patients

received stable doses of MTX of greater than or equal to 10 mg/week. After just

16 weeks of treatment, 62 percent of all patients receiving golimumab (combined

golimumab treatment groups) experienced at least 20 percent improvement in

arthritis symptoms (ACR 20), compared with 37 percent of placebo-treated

patients (P = 0.008). Additionally, at week 16, 31 percent of patients in the

combined golimumab treatment groups achieved ACR 50, and 12 percent

achieved ACR 70, compared with six percent and zero percent, respectively, of

patients in the placebo group. All individual golimumab treatment groups

achieved higher ACR 20 response rates than placebo. Golimumab 50 mg every four

weeks (63 percent) and golimumab 100 mg every two weeks (79 percent) were

statistically significantly more effective than placebo (37 percent) in

achieving an ACR 20 response (P = 0.031 and P < 0.001, respectively).

17th November 2005

http://www.pharmaceutical-business-review.com/article_news_print.asp?guid=DC7CC5\

B6-A93D-4F9A-B157-EE11593D1FF0 By

Results from a phase II rheumatoid arthritis study assessing the safety and

efficacy of Centocor and Schering-Plough's drug, golimumab, showed that it

significantly improved symptoms in a majority of patients. In this dose-ranging

trial, more than 60% of patients with moderately to severely active rheumatoid

arthritis (RA) treated with golimumab and methotrexate experienced at least 20%

improvement in arthritis symptoms at week 16. Additionally, one-quarter of

patients receiving golimumab and MTX achieved remission as evaluated by Disease

Activity Score 28.

" When treating a debilitating disease like RA, it is important to have several

treatment options, and we are encouraged by the safety and efficacy data we have

seen thus far for golimumab, " said Dr Kay, director, Clinical Trials,

Rheumatology Unit, Massachusetts General Hospital, and lead study investigator.

Golimumab is a fully-human anti-TNF-alpha IgG1 monoclonal antibody that

targets and neutralizes both the soluble and the membrane-bound form of

TNF-alpha. The drug is currently being investigated for administration by either

subcutaneous injection or intravenous infusion.

http://arthritis.about.com/b/a/257354.htm Golimumab (CNTO 148) Recruiting

for Phase III Trials Golimumab (CNTO 148) was called promising after the

release of Phase II clinical trial results last November. Golimumab (CNTO 148)

targets tumor necrosis factor alpha. In the Phase II trial, 62 percent of

patients treated with golimumab and methotrexate had at least 20 percent

improvement in rheumatoid arthritis symptoms, according to Medical News Today.

In Phase III trials, Golimumab will be given once monthly as a subcutaneous

injection. Bi-weekly and once monthly doses had been tested in Phase II.

Golimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody,

may become a good alternative to Remicade for some patients.

According to ClinicalTrials.gov, there are currently five trials involving

Golimumab which are recruiting study participants:

A Study of the Safety and Efficacy of Golimumab in Subjects With Active

Rheumatoid Arthritis Despite Methotrexate Therapy

A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid

Arthritis That Are Methotrexate-Naive

A Study of the Safety and Efficacy of Golimumab in Patients With Active

Psoriatic Arthritis

A Study of the Safety and Efficacy of Golimumab in Subjects With Active

Ankylosing Spondylitis

A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With

Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNF alpha

agents

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(Beautiful Southern Oregon, USA)

We may not be able to change the direction of the wind, but we can adjust our

sails.

May you have enough happiness to make you kind, enough trials to make you

strong, enough sorrow to keep you human, enough hope to make you happy.

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