Rheumatoid Arthritis Drug Trials for Tasocitinib aka CP-690550
Phase 3 Rheumatoid Arthritis drug trials mean more widespread testing of Tasocitinib aka CP-690550
Last night, I learned some exciting news about a new kind of Rheumatoid Arthritis drug in development called Tasocitinib. Tasocitinib is administered in a pill form. However, it is being compared to Biologics which are administered intravenously or injected.
Tasocitinib, also known as CP-690550, is a JAK (Janus kinase) inhibitor with immunosuppressive properties. It has also been used to prevent transplant rejection. It promises to “overcome” some limitations of Biologics “by selectively targeting JAK, which is expressed generally only in immune cells,” Pub Med.
The exciting news is that Tasocitinib is now in Phase 3 clinical trials. That means more widespread testing across the US and 35 countries altogether. Pfizer has set up an RA website just for the ORAL clinical trials for this new RA drug.
Rheumatoid Arthritis drugs in development go through four phases. The Phase 2 ORAL trials showed promising results against methotrexate and Humira (adalimumab). There are more details about phase 2 in this Medical News Today article.
Arms in the CP-690550 Rheumatoid Arthritis drug trials
There are two different RA drug trials. That means that, for Phase 3, there are two groups of people being studied in different ways. Which study a potential patient would qualify to enter depends on treatment history.
ORAL trial 1032 is for patients who had an inadequate response to TNF inhibitors (that’s Biologics like Enbrel or Humira). Tasocitinib will be tested with methotrexate as a “background” drug. ORAL trial 1069 compares the effectiveness of Tasocitinib to methotrexate in preventing joint damage and improving Rheumatoid Arthritis symptoms.
If you might consider participating in one of the Tasocitinib / CP-690-550 ORAL trials, there is a map on their website of cities which have participating locations. There is also a toll free number and a page which discusses issues related to clinical trials. If you call, please mention that you read about it here. I had a very nice conversation with a representative I interviewed last night.
3/09/11 UPDATE: Tofacitinib / CP-690550 aka Tasocitinib Succeeds in Pfizer’s 2nd Phase 3 Trial
Recommended reading:
- What Is it Like to Have Rheumatoid Arthritis? Part 2: Why Don’t They Tell You?
- How well do Biologic medications help Rheumatoid Arthritis?
- Rheumatoid Arthritis News: Actemra Approved
- The Problem with Rheumatoid Arthritis Information: Why is RA so hard to study and cure?
- Ultrasound for Rheumatoid Arthritis, Part 1
Tasocitinib – I´ve been to one of the session with Ron Fleischman and thought, there’s s./th. to it, but better wait for results of the phase III trials. Could be a good addition to the existing medications as it is orally given.
Kelly, when you take part in testing, do you know if you can choose to get the “real” drug and not a placebo? Because if I get a placebo I’ll end up in the hospital, or bedridden at the very least because my RA is so bad…what little benefit I’m getting from Enbrel is what’s keeping me barely functioning…
Diane,
I’d call them to clarify. The study would have to be “blind” which means that you cannot know whether you get a placebo or the study drug. You would be in one of 2 groups, depending on your history.
However, the way understand it, even if you get the placebo, you would still get methotrexate, but better ask them to be sure.
The list of participating doctors doesn’t seem to be complete. My Rhumetologist office is participating and I don’t see his office listed. I received a card asking if I was interested from Pfizer and the doc office.
Mary, thanks for the tip. :chic:
Mary,
You are right, it isn’t complete. I was able to talk to this group as well and told them I’d be happy to apply for the trial and then follow up next year with any successes. Then I saw LA wasn’t on the map? But apparently there are 2 LA locations. So if anyone is interested call, even if it’s not on the map!
Nevermind Kelly…I went to the Pfizer website…I’m not close enough to any trial locations. Thanks for posting this though…it looks promising!
Seems Mary says we have to ask directly since all offices are not on the site.
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Diane, hi. I have been doing this drug trial since last March. The drug didn’t have a name when I started it. It is a 6 month trial that has an option to go into a long-term or open-label study. I have actually moved into the open-label portion of the study which I’ll explain in a little bit.
You will have to have a complete physical with lots of bloodwork. You will also have to go off of most, if not all of your current RA meds. You still can take NSAIDs.
The 6-month study is a double-blind study. That means several things.
FIRST BLIND: This is months 1-3 of the study. There is a chance that you will get a placebo. You have a 1 in 5 chance of NOT getting drug. If you DO get drug, you will have one of the following doses per day…..5 mg a day, 10 mg a day, 15 mg a day, 20 mg a day. If you are on placebo, rescue drugs can be prescribed if need be.
SECOND BLIND: This is months 4-6 of the study. No matter if you were on placebo or not for months 1-3, you will be on drug now. If youwere on drug, your dosing will not change. If you were on placebo, you will get one of the aformentioned doses.
During the 6 months, you have to keep regular doctors appointments. Your first appointment will come 2 weeks afer you recieve your trial meds. Then you will go again in 2 more weeks. Then it’s once a month. DUring this study, neither you or the study docs can know your sed rate. Your cholesterol and liver functions will be monitored. The docs will know those results. If there is a problem with either of those, they will alert you.
If after the clinical trial is over and you have responded well, you can continue on with the open label study. During this time, you will know your dosage and it can be adjusted as needed. This will be long-term.
All of your care and testing and the drug is free.
There was a girl in my group who did get the placebo. He ended up on rescue meds and did end up worse off than she was in the beginning. She chose to stick it out and within a wek of being on the drug during the second part of the blind (month 3) she saw marked improvements. She is now in the open-label portion along with me and she is not on any other med…..not even NSAIDs.
I have not taken any other med for mt RA since I’ve been on this drug.
It is looking VERY promisingthat Taso will be approved by the FDA. I guess you’ll have to check with your doc and weigh your options. If you can take the risk (1 in 5) it may be well worth it.
Best of luck!
Angie
PS> If you google CP690550 you should be able to find the study. If not, let me know and I can email you a copy because I still have mine.
That is exciting news! It could change things in a major way. Here’s hoping.
I was on the Humira/taso study for 12 months along with methetrexate & improved so I had no swollen joints-the first time in 25 years. I am now on the open study of taso for just 3weeks but am missing the humira a little
Noel, were you getting a combination??
Sera que servira igual para la enefermedad de Crohn.
is this trial being done in canada and if it is not yet , do they have a date. i am on orencia at the moment still have bad days that outweigh the good ones. this trial sounds promising and of course i want to get on the list when and if it comes up here. thanks maggie
Maggie, you should search Clinical trials 690550 Canada. It would take some time to find out if any are open in your area. I’m working to find out if there is one in Florida, so I know it can take time. Even if they are listed as open, they may be full – at least here in the states. Maybe in a couple of years it will be available to more of us.
I have been on this life changing medicine for 8 months and it is amazing, in Phase 4 now…living and loving life again
I wanted more information on locations of trials and studies. The links on this website don’t work. http://www.oraltrials.com and http://www.oraltrials.com/knowledge-base/understanding-clinical-trials/
I would really like to know more about tasocitinib. I haven’t taken lots of RA drugs and everything has stopping working. Right now I’m not taking anything since there is nothing new available on the market.
Hi Mary – I think that’s because most of those trials are closed, although there are other ones going on now. The drug was forced to change its name to Tofacitinib and there’s a newer post here on the blog about it. This may be available within a year or so and there is another type oral med that is probably going to be available soon.
Kelly, I am very interested in the new Biologic drug trial.
I tried your link to Tasocitinib trials and the other links to get a phone number to call them. Both links do not work.
Please advise.
Thanks
Steve, please go to clinicaltrials.gov and search for your location. That trial site is over a year old now so maybe they have a new number. The best way to keep up w/it is that .gov site. Good luck!! lmk how it goes.
Hi Kelly and thanks for the quick reply. I knew about this drug a tear ago when it was in stage 2. I was on UCB doing a survey with others for Cimzia and that’s when I learned about it. When I saw the article on your web site at stage 3, I wanted to get more information if they needed people for testing. I tried your link below that I received in your reply but still can not access they site.
“Pfizer has set up an RA website just for the ORAL for this new RA drug.” I do belong to Clinicaltrials.gov and have done some survey’s with them in the past.
Thanks for the help.
PS, I have been a member of RA Warrior for a long time and want to say thank you Kelly for all the time and effort you put into the RA community with your web site. I am a friend of Karen Ager who wrote “Enemy Within” and know she is a member to. You do a great job with everyone and I personally want to thank you for some of the past year information that I was able to use to help with my RA/OA/Fibromyalgia among other things.
Thanks again Kelly
Steve P.
thanks Steve. I was on my way out the door to pick up granola bars for the trip & I’m trying to catch a plane in the a.m. so I was rushed – I hope I didn’t confuse you. I was saying that since they set up that site to find patients for phase 3, it might not be working any more – a year later. When I tried to get into a trial last yr, I found the only really helpful way is to pay close attention to the info on the .gov site & make lots of calls to any rheums w/in a couple hours who might be involved in trials. That’s how I found the one I”ve been in for the last 8 months – by cold-calling. Certain rheum offices tend to do lots of trials – if you find one that’s near enough, they may keep your name on file & call you when they have something you can fit into.
Anyway, thanks for taking time – we all support each other in this & I need it just as much as others do 🙂
I have been on this drug for almost three years now.I was in the double blind study,also before it was named,and they had 5Mg,and 10Mg,now everyone gets the 10Mg.
I am now over one year in the open label study,at MCRC Dallas,under Dr.s Fleismann and Cohen,and my results have been mixed,I’ve gotten pretty good relief from this drug,and my flair-ups are not as numerous,or as painful,but I am still having them.
Before I was in the Cimzia study,and I got very little relief.This drug Tasocitinib is showing a lot of promise,though I have had some side effects,such as a dry,unproductive cough,fatigue,maybe just from the RA,I am about to enter the second year of the open label study……the best relief I got was from the Remicade,but I really don’t like needles so the oral meds are better suited to my lifestyle…..good luck and good health to all of you on the studies and suffering though RA.
K
Thanks so much for your input, Kurt. And best of luck with the continued tofacitinib /tasocitinib treatment. Wonder what the brand name will be when it’s approved?
Can not access the link to the clinical trials web site
Steve, Just search clinicaltrials.gov – it is a government website where you can search all clinical trials in the U.S. Maybe their site was down?