Assessment of safety, pharmacokinetics and efficacy in a combination treatment with SMP-114

Phase 2

• Conditions: Rheumatoid arthritis (RA); Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN32398235
• Lead Sponsor: Dainippon Sumitomo Pharma Europe Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-23
• Study Completion: 2008-07-21
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female patients aged at least 18, with rheumatoid arthritis (RA) for a minimum of six months
2. Has been receiving methotrexate treatment (stable for eight weeks)
3. Has active disease classified as American College of Rheumatology (ACR) functional class of I, II or III

Exclusion Criteria

1. Has previously discontinued DMARD therapy due to hepatic intolerance
2. Has received any DMARD in addition to methotrexate during the four weeks prior to randomisation
3. Is receiving more than two DMARDs in addition to methotrexate at the time of screening
4. Is receiving or has received gold, leflunomide or biological agents including tumour necrosis factor (TNF) or Interleukin 1 (IL-1) inhibitors within the eight weeks prior to randomisation
5. Has previously failed two or more DMARDS

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of SMP-114 (120 mg and 240 mg) versus placebo in terms of the percentage of patients meeting the ACR criteria for 20% improvement in RA (ACR20) at week 24.

Secondary Outcome Measures

Name	Time	Method
<br> 1. The efficacy of SMP-114 (120 mg and 240 mg) versus placebo after 24 weeks in terms of:<br> 1.1. ACR50<br> 1.2. ACR70<br> 1.3. Disease Activity Score-28 (DAS28)<br> 1.4. European League Against Rheumatism (EULAR) response<br> 2. The efficacy of SMP-114 versus placebo in terms of change in:<br> 2.1. Core variables<br> 2.2. Time to response<br> 2.3. Quality of life<br> 2.4. Radiological measurements of joint damage<br> 2.5. Assessment of safety and tolerability<br> 2.6. Pharmacokinetics (PK) measurements<br>