To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Sponsor
Sun Pharmaceutical Industries Limited (Industry)
Overall Status
Terminated
CT.gov ID
NCT02534896
Collaborator
(none)
150
20
3
31
7.5
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
Study Start Date
:
Nov 1, 2015
Actual Primary Completion Date
:
Mar 1, 2018
Actual Study Completion Date
:
Jun 1, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment 1: Sunpharma1505 (Low dose) and Placebo
|
Drug: Treatment I
Sunpharma1505 and Placebo
|
| Experimental: Treatment II: Sunpharma1505 (High Dose) and Placebo
|
Drug: Treatment II
Sunpharma1505 and Placebo
|
| Active Comparator: Treatment III: Reference1505 and Placebo
|
Drug: Treatment III
Reference1505 and Placebo
|
Outcome Measures
Primary Outcome Measures
- Good/Moderate European League Against Rheumatism Responders [week 1]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Pharma Site 17 | Brussels | Belgium | ||
| 2 | Sun Pharma Site 18 | Brussels | Belgium | ||
| 3 | Sun Pharma Site 21 | Brussels | Belgium | ||
| 4 | Sun Pharma Site 22 | Brussels | Belgium | ||
| 5 | Sun Pharma Site 23 | Brussels | Belgium | ||
| 6 | Sun Pharma Site 16 | Leuven | Belgium | ||
| 7 | Sun Pharma Site 19 | Liege | Belgium | ||
| 8 | Sun Pharma Site 20 | Merksem | Belgium | ||
| 9 | Sun Pharma Site 11 | Amsterdam | Netherlands | ||
| 10 | Sun Pharma Site 9 | Amsterdam | Netherlands | ||
| 11 | Sun Pharma Site 6 | Enschede | Netherlands | ||
| 12 | Sun Pharma Site 4 | Heerlen | Netherlands | ||
| 13 | Sun Pharma Site 7 | Hilversum | Netherlands | ||
| 14 | Sun Pharma Site 2 | Leeuwarden | Netherlands | ||
| 15 | Sun Pharma Site 8 | Lelystad | Netherlands | ||
| 16 | Sun Pharma Site 10 | Rotterdam | Netherlands | ||
| 17 | Sun Pharma Site 3 | Rotterdam | Netherlands | ||
| 18 | Sun Pharma Site 5 | Sneek | Netherlands | ||
| 19 | Sun Pharma Site 14 | Uden | Netherlands | ||
| 20 | Sun pharma Site 01 | Utrecht | Netherlands |
Sponsors and Collaborators
- Sun Pharmaceutical Industries Limited
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT02534896
Other Study ID Numbers:
- CLR_15_05
First Posted:
Aug 28, 2015
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment I : Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo |
|---|---|---|---|
| Arm/Group Description | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 |
| Period Title: Overall Study | |||
| STARTED | 49 | 52 | 49 |
| COMPLETED | 45 | 51 | 48 |
| NOT COMPLETED | 4 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Treatment I: Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 | Total of all reporting groups |
| Overall Participants | 49 | 52 | 49 | 150 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
55.3
(13.79)
|
56.4
(10.74)
|
56.7
(11.18)
|
56.1
(11.89)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
38
77.6%
|
42
80.8%
|
35
71.4%
|
115
76.7%
|
| Male |
11
22.4%
|
10
19.2%
|
14
28.6%
|
35
23.3%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
2%
|
1
1.9%
|
1
2%
|
3
2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
1
2%
|
1
1.9%
|
2
4.1%
|
4
2.7%
|
| White |
46
93.9%
|
49
94.2%
|
43
87.8%
|
138
92%
|
| More than one race |
1
2%
|
1
1.9%
|
3
6.1%
|
5
3.3%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Good/Moderate European League Against Rheumatism Responders |
|---|---|
| Description | |
| Time Frame | week 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat population |
| Arm/Group Title | Treatment I : Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo |
|---|---|---|---|
| Arm/Group Description | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 |
| Measure Participants | 49 | 52 | 49 |
| Count of Participants [Participants] |
42
85.7%
|
45
86.5%
|
32
65.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Treatment I : Sunpharma1505 (Low Dose) and Placebo, Treatment III: Reference1505 and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | ||
| Method | Hochberg and Gatekeeping | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Treatment II: Sunpharma1505 (High Dose) and Placebo, Treatment III: Reference1505 and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | Hochberg and Gatekeeping | |
| Comments | ||
| Title | Good European League Against Rheumatism -Responders |
|---|---|
| Description | |
| Time Frame | Day 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| intent-to-treat |
| Arm/Group Title | Treatment I : Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo |
|---|---|---|---|
| Arm/Group Description | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 |
| Measure Participants | 49 | 52 | 49 |
| Count of Participants [Participants] |
21
42.9%
|
26
50%
|
10
20.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Treatment I : Sunpharma1505 (Low Dose) and Placebo, Treatment III: Reference1505 and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.028 |
| Comments | ||
| Method | Hochberg and Gatekeeping | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Treatment II: Sunpharma1505 (High Dose) and Placebo, Treatment III: Reference1505 and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Hochberg and Gatekeeping | |
| Comments | ||
| Title | Good/Moderate European League Against Rheumatism Responders |
|---|---|
| Description | |
| Time Frame | Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment I : Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo |
|---|---|---|---|
| Arm/Group Description | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 |
| Measure Participants | 49 | 52 | 49 |
| Count of Participants [Participants] |
42
85.7%
|
43
82.7%
|
42
85.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Treatment I : Sunpharma1505 (Low Dose) and Placebo, Treatment III: Reference1505 and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.960 |
| Comments | ||
| Method | Hochberg and Gatekeeping | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Treatment II: Sunpharma1505 (High Dose) and Placebo, Treatment III: Reference1505 and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.339 |
| Comments | ||
| Method | Hochberg and Gatekeeping | |
| Comments | ||
| Title | Good European League Against Rheumatism Responders |
|---|---|
| Description | |
| Time Frame | Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment I : Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo |
|---|---|---|---|
| Arm/Group Description | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 | solution for injection/infusion Day 1 and 15 |
| Measure Participants | 49 | 52 | 49 |
| Count of Participants [Participants] |
24
49%
|
33
63.5%
|
21
42.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Treatment I : Sunpharma1505 (Low Dose) and Placebo, Treatment III: Reference1505 and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.573 |
| Comments | ||
| Method | Hochberg and Gatekeeping | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Treatment II: Sunpharma1505 (High Dose) and Placebo, Treatment III: Reference1505 and Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.374 |
| Comments | ||
| Method | Hochberg and Gatekeeping | |
| Comments | ||
Adverse Events
| Time Frame | Week 12 | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Treatment I: Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo | |||
| Arm/Group Description | Treatment I: Treatment I and Placebo | Treatment II: Treatment II and Placebo | Treatment III: Treatment III and Placebo | |||
All Cause Mortality |
||||||
| Treatment I: Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/52 (0%) | 0/49 (0%) | |||
Serious Adverse Events |
||||||
| Treatment I: Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/49 (8.2%) | 1/52 (1.9%) | 2/49 (4.1%) | |||
| Gastrointestinal disorders | ||||||
| Vomiting | 1/49 (2%) | 0/52 (0%) | 0/49 (0%) | |||
| Immune system disorders | ||||||
| Hypersensitivity | 1/49 (2%) | 1/52 (1.9%) | 0/49 (0%) | |||
| Infections and infestations | ||||||
| Viral upper respiratory tract infection | 0/49 (0%) | 0/52 (0%) | 1/49 (2%) | |||
| Injury, poisoning and procedural complications | ||||||
| Infusion related reaction | 1/49 (2%) | 0/52 (0%) | 0/49 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 1/49 (2%) | 0/52 (0%) | 0/49 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Neuroendocrine carcinoma of the skin | 0/49 (0%) | 0/52 (0%) | 1/49 (2%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Treatment I: Sunpharma1505 (Low Dose) and Placebo | Treatment II: Sunpharma1505 (High Dose) and Placebo | Treatment III: Reference1505 and Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 42/49 (85.7%) | 46/52 (88.5%) | 39/49 (79.6%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 9/49 (18.4%) | 6/52 (11.5%) | 1/49 (2%) | |||
| General disorders | ||||||
| Fatigue | 6/49 (12.2%) | 6/52 (11.5%) | 5/49 (10.2%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 6/49 (12.2%) | 5/52 (9.6%) | 4/49 (8.2%) | |||
| Influenza | 3/49 (6.1%) | 2/52 (3.8%) | 0/49 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 2/49 (4.1%) | 3/52 (5.8%) | 4/49 (8.2%) | |||
| Nervous system disorders | ||||||
| Dizziness | 4/49 (8.2%) | 2/52 (3.8%) | 2/49 (4.1%) | |||
| Headache | 8/49 (16.3%) | 9/52 (17.3%) | 6/49 (12.2%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 4/49 (8.2%) | 2/52 (3.8%) | 4/49 (8.2%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Hyeprhidrosis | 1/49 (2%) | 6/52 (11.5%) | 3/49 (6.1%) | |||
| Vascular disorders | ||||||
| Hot flush | 4/49 (8.2%) | 6/52 (11.5%) | 6/49 (12.2%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Dr Mudgal Kothekar |
|---|---|
| Organization | SPARC |
| Phone | 912266455645 |
| clinical.trials@sparcmail.com |
Responsible Party:
Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier:
NCT02534896
Other Study ID Numbers:
- CLR_15_05
First Posted:
Aug 28, 2015
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021