Rheumatoid Arthritis (RA) Clinical Trial
Official title:
A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis.
To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the percentage of patients meeting the American College of Rheumatology criteria for 20% improvement in RA (ACR20) at week 24. The study hypothesis would be to demonstrate that the use of methotrexate and SMP-114 is more efficacious than Methotrexate alone.
Status | Terminated |
Enrollment | 312 |
Est. completion date | April 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patients aged at least 18 years, with RA for a minimum of 6 months - Has been receiving methotrexate treatment (stable for 8 weeks) - Has active disease classified as ACR functional class of I, II or III Exclusion Criteria: - Has previously discontinued DMARD therapy due to hepatic intolerance - Has received any DMARD in addition to methotrexate during the 4 weeks prior to randomisation - Is receiving more than 2 DMARDs in addition to methotrexate at the time of screening - Is receiving or has received Gold, leflunomide or biological agents including TNF/IL-1 inhibitors within the 8 weeks prior to randomisation - Has previously failed 2 or more DMARDS |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dainippon Sumitomo Pharma Europe LTd. |
Czech Republic, Germany, Hungary, Netherlands, Poland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the efficacy of SMP-114 versus placebo in terms of the percentage of patients meeting the ACR criteria for 20% improvement in RA (ACR20) at Week 24. | |||
Secondary | To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response. | |||
Secondary | To compare the efficacy of SMP-114 versus placebo in terms of change in core variables, time to response, Quality of Life, radiological measurements of joint damage, assessment of safety and tolerability, and PK measurements |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047341 -
A Study of Human Substance Balance and Biotransformation of [14C]SHR0302
|
Phase 1 | |
Withdrawn |
NCT02786563 -
Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate
|
||
Completed |
NCT03257852 -
A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
|
Phase 2 | |
Completed |
NCT03660059 -
A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)
|
Phase 3 | |
Recruiting |
NCT03971253 -
Japan Post-Marketing Surveillance for Peficitinib to Assess Safety and Effectiveness in the Patients With Rheumatoid Arthritis
|
||
Not yet recruiting |
NCT05486715 -
Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients
|
||
Completed |
NCT03682705 -
A Study to Investigate the Safety and Efficacy of ABBV-105 Alone or in Combination With Upadacitinib (ABBV-599 Combination) in Participants With Active Rheumatoid Arthritis
|
Phase 2 | |
Active, not recruiting |
NCT04574492 -
A Study of Oral Upadacitinib Tablets to Assess the Change in Disease Symptoms in Adult Canadian Participants With Moderate to Severe Rheumatoid Arthritis
|
||
Active, not recruiting |
NCT02805010 -
Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously
|
Phase 1 | |
Completed |
NCT01871961 -
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient
|
Phase 1 | |
Completed |
NCT04497597 -
A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis
|
||
Terminated |
NCT02775656 -
UCB Cimzia Pregnancy Follow-up Study
|
||
Completed |
NCT01173120 -
Methotrexate - Inadequate Response Device Sub-Study
|
Phase 3 | |
Completed |
NCT03223012 -
Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
|
||
Completed |
NCT03086343 -
A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
|
Phase 3 | |
Terminated |
NCT01569152 -
Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)
|
Phase 2 | |
Completed |
NCT02105129 -
A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523
|
Phase 1 | |
Completed |
NCT01577563 -
Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).
|
N/A | |
Completed |
NCT01618955 -
Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
|
Phase 2 | |
Completed |
NCT01618968 -
Comparison of Methotrexate (MTX) and the VIBEX™ MTX Device
|
Phase 2 |