A study looking at the safety, tolerability absorption, breakdown, and elimination of SCH 900117 from the body in Healthy Volunteers and patients with Rheumatoid Arthritis.

• Conditions: Rheumatoid Arthritis; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12608000555358
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Part 1-Healthy volunteers

Part 2-Rheumatoid Arthritis >6mths
- >=5 swollen & tender joints

Exclusion Criteria

History of malignancy, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the Safety & Tolerability of SCH 900117 in healthy subjects and patients with Rheumatoid Arthritis.<br>(Assessed via vital sign measurements, standard laboratory safety tests, urinalysis &/or physical examinations)[Assessed throughout the study at each study visit . [Visit schedule Part 1: Daily visits up to Day 7 time point; Day 14; Biweekly until Week 16 (Day 112)] [Visit Schedule Part 2: Daily visits up to Day 7 time point; Day 14; Biweekly until Week 8; Week 9; Week 10; Week 12, Week 16; Monthly until week 24 (D168)]]

Secondary Outcome Measures

Name	Time	Method
To determine the Pharmacokinetics of SCH 900117 in healthy subjects and patients with Rheumatoid Arthritis.<br>(Assessed via pharmacokinetic blood sampling)[Assessed throughout the study at each study visit. [Visit Schedule Part 2: Daily visits up to Day 7 time point; Day 14; Biweekly until Week 8; Week 9; Week 10; Week 12, Week 16; Monthly until week 24 (D168)]]