Clinical trial NCT02534896: To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Official title: To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Active Rheumatoid Arthritis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Good/Moderate European League Against Rheumatism Responders
timeFrame: week 1
Secondary outcomes:
measure: Good European League Against Rheumatism -Responders
timeFrame: Day 8
measure: Good/Moderate European League Against Rheumatism Responders
timeFrame: Day 15
measure: Good European League Against Rheumatism Responders
timeFrame: Day 15
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Sun Pharma Site 17
city: Brussels
country: Belgium
facility: Sun Pharma Site 18
city: Brussels
country: Belgium
facility: Sun Pharma Site 21
city: Brussels
country: Belgium
facility: Sun Pharma Site 22
city: Brussels
country: Belgium
facility: Sun Pharma Site 23
city: Leuven
country: Belgium
facility: Sun Pharma Site 16
city: Liege
country: Belgium
facility: Sun Pharma Site 19
city: Merksem
country: Belgium
facility: Sun Pharma Site 20
city: Amsterdam
country: Netherlands
facility: Sun Pharma Site 11
city: Amsterdam
country: Netherlands
facility: Sun Pharma Site 9
city: Enschede
country: Netherlands
facility: Sun Pharma Site 6
city: Heerlen
country: Netherlands
facility: Sun Pharma Site 4
city: Hilversum
country: Netherlands
facility: Sun Pharma Site 7
city: Leeuwarden
country: Netherlands
facility: Sun Pharma Site 2
city: Lelystad
country: Netherlands
facility: Sun Pharma Site 8
city: Rotterdam
country: Netherlands
facility: Sun Pharma Site 10
city: Rotterdam
country: Netherlands
facility: Sun Pharma Site 3
city: Sneek
country: Netherlands
facility: Sun Pharma Site 5
city: Uden
country: Netherlands
facility: Sun Pharma Site 14
city: Utrecht
country: Netherlands
facility: Sun pharma Site 01
Study officials:
References: