NCT01010581

SC12267 (4SC-101) in Combination With Methotrexate in Patients With Rheumatoid Arthritis

A Randomized, Double Blind, Placebo-Controlled, Phase II Study to Evaluate Efficacy, Safety, and Pharmacokinetics of SC12267 (35 mg) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: 4SC AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the efficacy, safety and pharmacokinetics of SC12267 (4SC-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the treatment of patients suffering from Rheumatoid Arthritis.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SC12267 (4SC-101)	oral administration
DRUG	Placebo	oral administration
DRUG	Methotrexate	oral administration
DRUG	Folic Acid	oral administration

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-04-01
• Completion: 2011-07-01
• First posted: 2009-11-10
• Last updated: 2012-03-01

Locations

27 sites across 4 countries: Bulgaria, Czechia, Poland, Romania