Trial record 1 of 2 for:
GP2015
Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis (EQUIRA)
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ClinicalTrials.gov Identifier: NCT02638259 |
Recruitment Status :
Completed
First Posted : December 23, 2015
Results First Posted : February 23, 2018
Last Update Posted : September 19, 2018
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Sponsor:
Sandoz
Information provided by (Responsible Party):
Sandoz
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Rheumatoid Arthritis |
Intervention |
Drug: GP2015 |
Enrollment | 376 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 50mg GP2015 | 50mg EU-authorized Enbrel |
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Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator | Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator |
Period Title: Treatment Period 1 | ||
Started | 186 | 190 |
Completed | 181 | 172 |
Not Completed | 5 | 18 |
Reason Not Completed | ||
Adverse Event | 1 | 5 |
Death | 0 | 1 |
Lack of Efficacy | 0 | 1 |
Protocol Violation | 0 | 3 |
Withdrawal by Subject | 4 | 6 |
Withdrawn per sponsor decision | 0 | 2 |
Period Title: Treatment Period 2 | ||
Started | 175 [1] | 166 [2] |
Completed | 169 | 155 |
Not Completed | 6 | 11 |
Reason Not Completed | ||
Adverse Event | 5 | 4 |
Withdrawal by Subject | 1 | 7 |
[1]
6 patients did not proceed to TP2 (3 not eligible, 2 consent withdrawal, 1 IP delay)
[2]
6 patients did not proceed to TP2 (4 not eligible, 1 consent withdrawal, 1 adverse event).
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Baseline Characteristics
Arm/Group Title | 50mg GP2015 | 50mg EU-authorized Enbrel | Total | |
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Group 1 received treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continued treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator | Group 2 received treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response were switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). GP2015: Enbrel comparator | Total of all reporting groups | |
Overall Number of Baseline Participants | 186 | 190 | 376 | |
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Baseline characteristics are presented for Full Analysis Set (FAS). The FAS is comprised of all randomized patients to whom study treatment has been assigned.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 186 participants | 190 participants | 376 participants | |
55.2 (11.22) | 53.1 (12.70) | 54.1 (12.02) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 186 participants | 190 participants | 376 participants | |
Female |
158 84.9%
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150 78.9%
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308 81.9%
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Male |
28 15.1%
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40 21.1%
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68 18.1%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 186 participants | 190 participants | 376 participants | |
American Indian or Alaska Native |
1 0.5%
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1 0.5%
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2 0.5%
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Asian |
0 0.0%
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3 1.6%
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3 0.8%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
5 2.7%
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1 0.5%
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6 1.6%
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White |
180 96.8%
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185 97.4%
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365 97.1%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 186 participants | 190 participants | 376 participants |
Hungary |
7 3.8%
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12 6.3%
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19 5.1%
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United States |
23 12.4%
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26 13.7%
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49 13.0%
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Czechia |
16 8.6%
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15 7.9%
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31 8.2%
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United Kingdom |
3 1.6%
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4 2.1%
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7 1.9%
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Spain |
5 2.7%
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5 2.6%
|
10 2.7%
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Russia |
12 6.5%
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10 5.3%
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22 5.9%
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Latvia |
6 3.2%
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2 1.1%
|
8 2.1%
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Poland |
44 23.7%
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48 25.3%
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92 24.5%
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Italy |
1 0.5%
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0 0.0%
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1 0.3%
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Mexico |
4 2.2%
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5 2.6%
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9 2.4%
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Slovakia |
3 1.6%
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5 2.6%
|
8 2.1%
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Bulgaria |
11 5.9%
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11 5.8%
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22 5.9%
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Lithuania |
9 4.8%
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12 6.3%
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21 5.6%
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Serbia |
12 6.5%
|
10 5.3%
|
22 5.9%
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Germany |
4 2.2%
|
5 2.6%
|
9 2.4%
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Estonia |
26 14.0%
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20 10.5%
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46 12.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Terms related to publication are part of the contract templates between Sponsor and sites/investigators. In general, these terms outlined that authorship of any publications relating to the clinical study shall be determined by agreement with the Sponsor. Sponsor reserves the right to request amendments or deletions to proposed publications, or request that any publication or presentation be delayed up to four months. A very limited number of exceptions can be granted to modify these terms.
Results Point of Contact
Name/Title: | Sandoz Biopharma Clinical Development - Strategic Planning |
Organization: | Sandoz |
Phone: | 0049(0)80244760 |
EMail: | biopharma.clinicaltrials@sandoz.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sandoz |
ClinicalTrials.gov Identifier: | NCT02638259 |
Other Study ID Numbers: |
GP15-301 |
First Submitted: | December 16, 2015 |
First Posted: | December 23, 2015 |
Results First Submitted: | December 19, 2017 |
Results First Posted: | February 23, 2018 |
Last Update Posted: | September 19, 2018 |