This is a clinical trial for
Patients with Rheumatoid Arthritis
For some people with moderate or severe Rheumatoid Arthritis (RA) symptoms, medications that have traditionally been used for the treatment of RA may not work well enough or may cause unwanted side effects. This study is for people whose RA has not responded well enough to previous treatment with methotrexate, and will be comparing the investigational medication with adalimumab (an approved treatment for RA) and placebo (which looks the same as the investigational medication, but contains no actual medicati
The study drug (GDC-0853, Adalimumab, Folic Acid, and Methotrexate) is administered by Tablets, Pills, or Capsules.
This is a phase 2 trial. What does this mean? A phase 2 trial means that the study drug has been taken by other participants under the supervision of medical professionals.
There will be 580 participants in this trial, at 11 sites around the world
- be between 18 – 75 years old
- have rheumatoid arthritis (RA) that has not responded to treatment with methotrexate.
Participants must not:
- have previously been treated with any biologic drugs
- have any other inflammtory joint disease or autoimmune disorder
This trial is 6 weeks long, requiring 10 visits and 0 overnight stays.
A placebo is being used for this trial.
The sponsor of this trial is Genentech.
The results of this trial will be published.
Patients will be able to continue with the study medication if doctors agree that it would be appropriate to do so.
All study related medications, analysis, hospital visits, and procedures are free.
This study will take place in 1 country
11 sites will be participating.
- Dallas, Arthritis Care and Research Center-BRI, 75231
- Houston, Glacier View Research Instutute-Rheumatology, 77004
- Victoria, Crossroads Clinical Research, 77901
- Dallas, Metroplex Clinical Research Center, 75231
- Boynton Beach, Orthopedic Research Institute, 33437
- Orlando, Omega Research Consultants, 32804
- Clearwater, Clinical Research of West Florida - Corporate, 33765
- Anniston, Pinnacle Research Group, 36207
- Wyomissing, Clinical Research Center of Reading, 19610
- El Cajon, TriWest Research Associates, LLC, 92020-4124
- Phoenix, Arizona Arthritis & Rheumatology Research, 85297
Information about this Study is provided on this website so you can learn about the Study. This may help you decide whether this Study is right for you. It may also be useful in your discussions with your doctor, family and care provider. The information is not intended to be promotional. The drug being studied has not been approved by the FDA, EMA or other regulatory agency for the disease being studied.
Frequently asked questions
What are clinical trials?
Clinical trials are research studies to determine whether investigational drugs or treatments are safe and effective for humans. All new investigational medications and devices must undergo several clinical trials, often involving thousands of people.
Can I quit a trial?
You can quit a clinical trial at any time and you do not have to give a reason. There is no charge or penalty for quitting.
Why participate in a clinical trial?
You will have access to new investigational treatments that would be available to the general public only upon approval. You will also receive study-related medical care and attention from clinical trial staff at research facilities. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
What are the benefits and risks of clinical trials?
You may or may not receive direct clinical benefit from this study but your participation will provide important information to help researchers learn more about the condition and possibly develop better treatments for future patients.
Is my information safe?
The Study Information is used only for research purposes and will be kept confidential within the limits of the law of your country. If the results of this study are published or presented in a meeting, you will not be named and nobody will be able to tell that you were in the study from the publication or presentation.
Any other questions?
If you would like to speak to someone regarding this trial fill in this quick questionnaire. If you are eligible someone from the research team will contact you by phone and explain everything in more detail.
You are under no obligation to proceed even if you fill it in and can drop out at any point.