 |
Welcome to the first Edelweiss Newsflash! We’re planning to send a newsflash every other month as a complement to the monthly study newsletters. If there’s information that you aren’t finding in other Edelweiss communications, let us know and we’ll see if we can include it here. In the meantime, many thanks to everyone at study sites working hard to keep Edelweiss moving! Keep up the great work!
Extension Study
Eligible subjects who have completed the 6-month study treatment period may enter the extension study for 6 additional months of active treatment (no placebo control). Subjects who previously received placebo will be randomly switched to one of the two active treatments (75 mg alone or 200 mg + ABT). Subjects who received active treatment will continue with the same treatment.
Please remember to inform subjects, at the Month 5 visit, of the opportunity to enter the extension study at Month 6 (if eligible) and provide them with a copy of the extension study fact sheet to read prior to their Month 6 visit.
Reminders
You can access referral information via the MMG ClinKit portal.
How? Go to the study website https://clinkit.mmgct.com/edelweissstudy and login with your username (not your email address). Your username was included in your original welcome invitation sent from the following email: Admin Study EdelweissEndoStudy@mmgct.com
If you forget your password for MMG ClinKit, you can reset it.
How? Go to the study website https://clinkit.mmgct.com/edelweissstudy and login with your username. Select “reset password” and input your username, not your email address. A link will be sent directly to the user to create a password.
You have been assigned a Recruitment Specialist for the Edelweiss study.
If you have any questions for MMG about referrals or recruitment, please contact your assigned Recruitment Specialist:
|
MMG Patient Recruitment Campaign
As many of you are aware, MMG is conducting an outreach campaign to help augment your recruitment efforts by generating more interest and referrals for each site. Please keep in mind that the screener that was developed to help pre-screen potential referrals was developed with input from Covance and ObsEva. The study team and MMG chose to keep the eligibility criteria more open so that we were not eliminating anyone who could potentially be a good candidate because they did not understand a question. We are relying on your experience with the protocol to follow up with the referrals and conduct additional screening to determine eligibility for the study. We truly appreciate all your efforts and look forward to continuing to work with all sites on the Edelweiss study.
|
|
|
|
