NCT02534896

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2015

Typical duration for phase_3

Geographic Reach
2 countries

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 21, 2019

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

2.3 years

First QC Date

August 25, 2015

Results QC Date

May 2, 2019

Last Update Submit

November 18, 2021

Conditions

Active Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Good/Moderate European League Against Rheumatism Responders

    week 1

Secondary Outcomes (3)

  • Good European League Against Rheumatism -Responders

    Day 8

  • Good/Moderate European League Against Rheumatism Responders

    Day 15

  • Good European League Against Rheumatism Responders

    Day 15

Study Arms (3)

Treatment 1: Sunpharma1505 (Low dose) and Placebo

EXPERIMENTAL
Drug: Treatment I

Treatment II: Sunpharma1505 (High Dose) and Placebo

EXPERIMENTAL
Drug: Treatment II

Treatment III: Reference1505 and Placebo

ACTIVE COMPARATOR
Drug: Treatment III

Interventions

Treatment IDRUG

Sunpharma1505 and Placebo

Treatment 1: Sunpharma1505 (Low dose) and Placebo
Treatment IIDRUG

Sunpharma1505 and Placebo

Treatment II: Sunpharma1505 (High Dose) and Placebo
Treatment IIIDRUG

Reference1505 and Placebo

Treatment III: Reference1505 and Placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects able and willing to give written informed consent and is available for entire study.
  • Male or female ≥ 18 years old
  • Willing and able to comply with the study protocol visits, assessments and accessible for follow up
  • Known Diagnosed Rheumatoid arthritis
  • Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator

You may not qualify if:

  • Subjects who are pregnant or intend to become pregnant during the study
  • 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.
  • 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.
  • Active infection requiring systemic treatment
  • Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Sun Pharma Site 17

Brussels, Belgium

Location

Sun Pharma Site 18

Brussels, Belgium

Location

Sun Pharma Site 21

Brussels, Belgium

Location

Sun Pharma Site 22

Brussels, Belgium

Location

Sun Pharma Site 23

Brussels, Belgium

Location

Sun Pharma Site 16

Leuven, Belgium

Location

Sun Pharma Site 19

Liège, Belgium

Location

Sun Pharma Site 20

Merksem, Belgium

Location

Sun Pharma Site 11

Amsterdam, Netherlands

Location

Sun Pharma Site 9

Amsterdam, Netherlands

Location

Sun Pharma Site 6

Enschede, Netherlands

Location

Sun Pharma Site 4

Heerlen, Netherlands

Location

Sun Pharma Site 7

Hilversum, Netherlands

Location

Sun Pharma Site 2

Leeuwarden, Netherlands

Location

Sun Pharma Site 8

Lelystad, Netherlands

Location

Sun Pharma Site 10

Rotterdam, Netherlands

Location

Sun Pharma Site 3

Rotterdam, Netherlands

Location

Sun Pharma Site 5

Sneek, Netherlands

Location

Sun Pharma Site 14

Uden, Netherlands

Location

Sun pharma Site 01

Utrecht, Netherlands

Location

Results Point of Contact

Title
Dr Mudgal Kothekar
Organization
SPARC
clinical.trials@sparcmail.com
912266455645

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2015

First Posted

August 28, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

November 19, 2021

Results First Posted

November 21, 2019

Record last verified: 2021-11

Locations

BE(8)NL(12)