Navigation Links
The use of placebo in rheumatoid arthritis clinical trials may negatively impact patients
Date:5/27/2011

The results of this study, conducted in Germany, re-open the debate on whether it is ethical to conduct placebo-controlled studies where patients in the placebo-group are at a serious disadvantage compared to patients taking the new treatments. The study analysed current study designs, for new therapies such as abatacept (Orencia), golimumab (Simponi) or tocilizumab (Actemra), and showed that patients in the placebo group experienced no change in medication, having to continue with their former, ineffective treatment plus placebo.

"According to the Helsinki-Declaration of the World Medical Association*, a placebo-controlled study design is deemed to be ethically acceptable when there is no other effective treatment," said Dr. Juche, Johanniter-Hospital, Treuenbrietzen, Germany. "However, this analysis confirms that patients in the placebo-group are at a disadvantage as they are given no change in medication to reduce their active inflammatory condition or halt disease progression. Our recommendation is that future clinical trials should include an active comparator group to ensure that all patients receive effective treatments to improve their quality of life."

In the analysis, researchers used studies from the European Public Assessment Report (EPAR) of the European Medicines Agency (EMA) for abatacept, golimumab and tocilizumab as samples. The studies chosen had to be placebo controlled at the beginning and state clinical relevant outcome criteria (e.g. DAS28**, ACR20***, Health Assessment Questionnaire and joint erosion scores).


'/>"/>

Contact: Rory Berrie
rory.berrie@cohnwolfe.com
44-790-151-3297
European League Against Rheumatism
Source:Eurekalert

Page: 1

Related biology news :

1. Goji berries have the same nutrients as fruits and vegetables and a placebo effect
2. New therapeutic target identified for rheumatoid arthritis
3. Anakinra for rheumatoid arthritis: A modest benefit with some risk
4. Gene therapy demonstrates benefit in patients with rheumatoid arthritis
5. Researchers identify new risk factor gene for rheumatoid arthritis
6. New trigger for chronic inflammation in rheumatoid arthritis discovered
7. BUSPH study links rheumatoid arthritis to vitamin D deficiency
8. Study confirms link between rheumatoid arthritis and COPD
9. Undertreatment of cardiovascular disease in rheumatoid arthritis patients following a heart attack
10. Geisinger research: Antimalarial drug prevents diabetes in arthritis patients
11. Inhibiting proteins may prevent cartilage breakdown in arthritis patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2017)... NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" ... its 2016 Annual Report on Form 10-K on Thursday April 13, ... ... the Investor Relations section of the Company,s website at http://www.nxt-id.com ... http://www.sec.gov . 2016 Year Highlights: ...
(Date:4/11/2017)... , April 11, 2017 Crossmatch®, ... secure authentication solutions, today announced that it has ... Advanced Research Projects Activity (IARPA) to develop next-generation ... program. "Innovation has been a driving ... Thor program will allow us to innovate and ...
(Date:4/11/2017)... 2017 NXT-ID, Inc. (NASDAQ:   NXTD ... the appointment of independent Directors Mr. Robin D. Richards ... of Directors, furthering the company,s corporate governance and expertise. ... Gino Pereira , Chief ... to their guidance and benefiting from their considerable expertise as ...
Breaking Biology News(10 mins):
(Date:10/11/2017)... (PRWEB) , ... October 11, 2017 , ... ... Administration (FDA) has granted orphan drug designation to SBT-100, its novel anti-STAT3 (Signal ... the treatment of osteosarcoma. SBT-100 is able to cross the cell membrane and ...
(Date:10/10/2017)... ... October 10, 2017 , ... Dr. Bob Harman, founder and CEO ... Diego Rotary Club. The event entitled “Stem Cells and Their Regenerative ... attendees. Dr. Harman, DVM, MPVM was joined by two human doctors: Peter B. ...
(Date:10/10/2017)... , ... October 10, 2017 , ... ... of 13 prestigious awards honoring scientists who have made outstanding ... a scheduled symposium during Pittcon 2018, the world’s leading conference and exposition for ...
(Date:10/9/2017)... ... October 09, 2017 , ... ... of medical marijuana products targeting the needs of consumers who are incorporating medical ... takes place in Phoenix, Arizona. , As operators of two successful Valley dispensaries, ...
Breaking Biology Technology: