Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-24 @ 9:33 PM
NCT ID:
NCT02270632
Brief Summary:
A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.
Detailed Description:
The study is designed to formally demonstrate the superiority of F8IL10 vs placebo and to further evaluate safety and efficacy of two different dosages of F8IL10 when administered to patients receiving MTX.
Patients will be enrolled and double-blind, parallel assigned (via automated randomization system) in a 1:1:1 fashion to one of three different arms:
* Arm 1: placebo + MTX
* Arm 2: F8IL10 30 µg/kg + MTX
* Arm 3: F8IL10 160 µg/kg + MTX
F8IL10 or placebo will be subcutaneously injected once a week for 8 weeks. Treatment will terminate at the earliest of the following: completion of the 8 weeks of therapy, withdrawal of informed consent, unacceptable toxicity/intolerability of the study drug or need to increase MTX, oral corticosteroids or NSAIDs dosages above baseline levels or need to introduce a new DMARD or biologic therapy to control rheumatoid arthritis activity. The study will be conducted in a double blind fashion.
Study:
NCT02270632
Study Brief:
Protocol Section:
NCT02270632