Clinical Trials Logo
  1. Home
  2. Active Rheumatoid Arthritis
  3. NCT02534896
  4. Details
NCT02534896 Clinical Trial

To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis

Active Rheumatoid Arthritis Clinical Trial

Official title:
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02534896
Other study ID # CLR_15_05
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date November 2015
Est. completion date June 2018

Study information
Verified date November 2021
Source Sun Pharmaceutical Industries Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.

Recruitment information / eligibility
Status Terminated
Enrollment 150
Est. completion date June 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: 1. Subjects able and willing to give written informed consent and is available for entire study. 2. Male or female = 18 years old 3. Willing and able to comply with the study protocol visits, assessments and accessible for follow up 4. Known Diagnosed Rheumatoid arthritis 5. Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator Exclusion Criteria: 1. Subjects who are pregnant or intend to become pregnant during the study 2. Subject with positive hepatitis panel and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]), and / or a positive Human immunodeficiency virus (HIV) antibody. 3. Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to IV medications, biologic therapy or IV radiocontrast agents. 4. Active infection requiring systemic treatment 5. Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Treatment I
Sunpharma1505 and Placebo
• Treatment II
Sunpharma1505 and Placebo
• Treatment III
Reference1505 and Placebo

Locations
Country Name City State
Belgium Sun Pharma Site 17 Brussels
Belgium Sun Pharma Site 18 Brussels
Belgium Sun Pharma Site 21 Brussels
Belgium Sun Pharma Site 22 Brussels
Belgium Sun Pharma Site 23 Brussels
Belgium Sun Pharma Site 16 Leuven
Belgium Sun Pharma Site 19 Liege
Belgium Sun Pharma Site 20 Merksem
Netherlands Sun Pharma Site 11 Amsterdam
Netherlands Sun Pharma Site 9 Amsterdam
Netherlands Sun Pharma Site 6 Enschede
Netherlands Sun Pharma Site 4 Heerlen
Netherlands Sun Pharma Site 7 Hilversum
Netherlands Sun Pharma Site 2 Leeuwarden
Netherlands Sun Pharma Site 8 Lelystad
Netherlands Sun Pharma Site 10 Rotterdam
Netherlands Sun Pharma Site 3 Rotterdam
Netherlands Sun Pharma Site 5 Sneek
Netherlands Sun Pharma Site 14 Uden
Netherlands Sun pharma Site 01 Utrecht

Sponsors (1)
Lead Sponsor Collaborator
Sun Pharmaceutical Industries Limited

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Good/Moderate European League Against Rheumatism Responders week 1
Secondary Good European League Against Rheumatism -Responders Day 8
Secondary Good/Moderate European League Against Rheumatism Responders Day 15
Secondary Good European League Against Rheumatism Responders Day 15
See also
  Status Clinical Trial Phase
Completed NCT04472481 - Vitamin D Effect in Rheumatoid Arthritis. Phase 4
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00959036 - Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis Phase 1/Phase 2
Completed NCT01961505 - Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis N/A
Completed NCT00393471 - Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis. Phase 3
Not yet recruiting NCT03346590 - Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects N/A
Completed NCT03172325 - Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA Phase 3
Completed NCT00420199 - A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate Phase 3
Recruiting NCT06456489 - Pulse Steroid Injection in Refractory Rheumatoid Arthritis Phase 3
Completed NCT00882024 - Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA) Phase 2
Completed NCT03599986 - Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis
Completed NCT02586246 - Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870 Phase 3
Completed NCT01008852 - Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis Phase 2