Trial record 1 of 1 for:
biosimilar adalimumab | Plaque Psoriasis | ADACCESS
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira (ADACCESS)
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ClinicalTrials.gov Identifier: NCT02016105 |
Recruitment Status :
Completed
First Posted : December 19, 2013
Results First Posted : April 7, 2017
Last Update Posted : May 30, 2017
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Sponsor:
Sandoz
Collaborator:
Hexal AG
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Plaque Type Psoriasis |
Interventions |
Drug: GP2017 Adalimumab Drug: Humira ® Adalimumab |
Enrollment | 465 |
Participant Flow
Recruitment Details | 661 patients were screened. 465 patients were randomized 1:1 into Treatment Period 1 and stratified by region (US/EU), body weight (<90/≥90 kg) and prior systemic therapy (no/any). In Treatment Period 2 patients were re-randomized 2:1 to either continue originally assigned treatment or switch treatment and were stratified by region only. |
Pre-assignment Details |
Screening lasted for at least 2 weeks and up to 4 weeks. Main inclusion criteria:
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Arm/Group Title | GP2017 Adalimumab | Humira ® Adalimumab | Humira ® Adalimumab Switched | Humira ® Adalimumab Continued | GP2017 Adalimumab Switched | GP2017 Adalimumab Continued |
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Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). | Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). | Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51). | Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period). | Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51). | GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period). |
Period Title: TREATMENT PERIOD 1 | ||||||
Started | 231 | 234 | 0 [1] | 0 [1] | 0 [1] | 0 [1] |
Completed | 201 [2] | 201 [3] | 0 | 0 | 0 | 0 |
Not Completed | 30 | 33 | 0 | 0 | 0 | 0 |
Reason Not Completed | ||||||
Protocol Violation | 2 | 8 | 0 | 0 | 0 | 0 |
Physician Decision | 0 | 2 | 0 | 0 | 0 | 0 |
Lack of Efficacy | 4 | 2 | 0 | 0 | 0 | 0 |
Pregnancy | 0 | 1 | 0 | 0 | 0 | 0 |
Adverse Event | 3 | 5 | 0 | 0 | 0 | 0 |
Withdrawal by Subject | 15 | 11 | 0 | 0 | 0 | 0 |
Lost to Follow-up | 6 | 4 | 0 | 0 | 0 | 0 |
[1]
Treatment arm applicable only in Treatment Period 2 and Extension Period
[2]
12 patients did not proceed into Treatment Period 2
[3]
11 patients did not proceed into Treatment Period 2
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Period Title: TREATMENT PERIOD 2 | ||||||
Started | 0 [1] | 0 [1] | 63 [2] | 127 [2] | 63 [3] | 126 [3] |
Completed | 0 | 0 | 57 | 116 | 59 | 112 |
Not Completed | 0 | 0 | 6 | 11 | 4 | 14 |
Reason Not Completed | ||||||
Non compliance study medication | 0 | 0 | 0 | 0 | 0 | 1 |
Lack of Efficacy | 0 | 0 | 2 | 6 | 3 | 2 |
Pregnancy | 0 | 0 | 0 | 0 | 0 | 1 |
Death | 0 | 0 | 0 | 0 | 0 | 1 |
Adverse Event | 0 | 0 | 0 | 4 | 0 | 1 |
Withdrawal by Subject | 0 | 0 | 3 | 1 | 1 | 7 |
Lost to Follow-up | 0 | 0 | 1 | 0 | 0 | 1 |
[1]
Treatment arm applicable for Treatment Period 1 only (patients re-randomized in Treatment Period 2)
[2]
Patients re-randomized from "Humira ® adalimumab" treatment arm in Treatment Period 1
[3]
Patients re-randomized from "GP2017 adalimumab" treatment arm in Treatment Period 1
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Period Title: EXTENSION PERIOD | ||||||
Started | 0 | 0 | 52 [1] | 109 [2] | 56 [3] | 106 [4] |
Completed | 0 | 0 | 47 | 104 | 50 | 100 |
Not Completed | 0 | 0 | 5 | 5 | 6 | 6 |
Reason Not Completed | ||||||
New therapy for study indication | 0 | 0 | 0 | 0 | 1 | 1 |
Lack of Efficacy | 0 | 0 | 1 | 3 | 1 | 1 |
Adverse Event | 0 | 0 | 2 | 0 | 1 | 0 |
Withdrawal by Subject | 0 | 0 | 2 | 2 | 2 | 2 |
Non-compliance with study indication | 0 | 0 | 0 | 0 | 1 | 0 |
Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 2 |
[1]
5 patients did not proceed from Treatment Period 2 into Extension Period
[2]
7 patients did not proceed from Treatment Period 2 into Extension Period
[3]
3 patients did not proceed from Treatment Period 2 into Extension Period
[4]
6 patients did not proceed from Treatment Period 2 into Extension Period
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Baseline Characteristics
Arm/Group Title | GP2017 Adalimumab | Humira ® Adalimumab | Total | |
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Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). | Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). | Total of all reporting groups | |
Overall Number of Baseline Participants | 231 | 234 | 465 | |
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The Full analysis set (FAS) consists of all randomized patients to whom a study treatment was assigned.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 231 participants | 234 participants | 465 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
205 88.7%
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208 88.9%
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413 88.8%
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>=65 years |
26 11.3%
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26 11.1%
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52 11.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 231 participants | 234 participants | 465 participants | |
45.6 (14.16) | 46.9 (14.09) | 46.3 (14.12) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 231 participants | 234 participants | 465 participants | |
Female |
89 38.5%
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92 39.3%
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181 38.9%
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Male |
142 61.5%
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142 60.7%
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284 61.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 231 participants | 234 participants | 465 participants |
United States | 188 | 190 | 378 | |
Europe | 43 | 44 | 87 |
Outcome Measures
Adverse Events
Limitations and Caveats
none reported
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.
The Sponsor shall have the right to the first publication or presentation of the results of the study which is intended to be a joint, multi-center publication of the study results. Following the first publication, institutions and/or Principal Investigators may publish or present data or results from the study per the terms of the clinical trial agreement.
Results Point of Contact
Name/Title: | Global Program Medical Director |
Organization: | Sandoz |
Phone: | +49 8024 476 ext 0 |
EMail: | biopharma.clinicaltrials@sandoz.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sandoz |
ClinicalTrials.gov Identifier: | NCT02016105 |
Other Study ID Numbers: |
GP17-301 2013-000747-11 ( EudraCT Number ) |
First Submitted: | December 14, 2013 |
First Posted: | December 19, 2013 |
Results First Submitted: | February 22, 2017 |
Results First Posted: | April 7, 2017 |
Last Update Posted: | May 30, 2017 |