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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
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz

Study Type Interventional
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
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:

  • Men or women of at least 18 years
  • Chronic plaque-type psoriasis ≥ 6 months before randomization
  • Moderate to severe psoriasis :

    • PASI score ≥ 12
    • IGA score ≥3
    • BSA affected by plaque-type psoriasis ≥ 10%
  • No previous exposure to adalimumab
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description 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
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
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
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
The Full analysis set (FAS) consists of all randomized patients to whom a study treatment was assigned.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 234 participants 465 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
205
  88.7%
208
  88.9%
413
  88.8%
>=65 years
26
  11.3%
26
  11.1%
52
  11.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 231 participants 234 participants 465 participants
Female
89
  38.5%
92
  39.3%
181
  38.9%
Male
142
  61.5%
142
  60.7%
284
  61.1%
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
1.Primary Outcome
Title PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab
Hide Description The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.
Time Frame At Week 16 only
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 197 196
Measure Type: Number
Unit of Measure: percent of participants
66.8 65.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GP2017 Adalimumab, Humira ® Adalimumab
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Adjusted response rates were estimated using a logistic regression model including treatment, body weight strata, region and prior systemic therapy. The 95% CI for the rate difference was derived based on the normal approximation and standard error computed using the delta method.To conclude equivalent efficacy, the 95% CI had to be entirely within the interval [-18%, 18%].
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-7.46 to 11.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.75
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)
Hide Description The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 197 196
Least Squares Mean (Standard Error)
Unit of Measure: percentage change from baseline
-60.7  (1.54) -61.5  (1.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GP2017 Adalimumab, Humira ® Adalimumab
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments

LS means, SE and 95% CI were estimated by a Mixed Model Repeated Measures (MMRM) model with treatment, visit, treatment-by-visit interaction, body weight strata, region and prior systemic therapy, as fixed factors and baseline PASI score as covariate.

Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira treatment was contained within the interval [-15%; 15%].

Method of Estimation Estimation Parameter LS means difference
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
-3.15 to 4.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)
Hide Description The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).
Time Frame Baseline to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 197 196
Least Squares Mean (Standard Error)
Unit of Measure: percentage change from baseline
-59.7  (1.59) 60.8  (1.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GP2017 Adalimumab, Humira ® Adalimumab
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments LSM, SE and 95% CI were estimated using an ANCOVA model with treatment, body weight strata, region and prior systemic therapy as fixed effects and baseline PASI score as covariate. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira was contained within the interval [−15%; 15%].
Method of Estimation Estimation Parameter LS means difference
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-2.78 to 5.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates
Hide Description Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)
Time Frame At Week 17 only
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 197 196
Measure Type: Number
Unit of Measure: percent of participants
% of patients achieving PASI50 at Week 17 93.2 92.8
% of patients achieving PASI75 at Week 17 71.4 68.6
% of patients achieving PASI90 at Week 17 51.6 44.8
% of patients achieving PASI100 at Week 17 21.9 16.5
5.Secondary Outcome
Title PASI 50, PASI75, PASI 90 and PASI100 Response Rates
Hide Description Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)
Time Frame At Week 35 only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description:

Humira 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).

Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.

GP2017 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 Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).

GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Overall Number of Participants Analyzed 51 115 55 105
Measure Type: Number
Unit of Measure: percent of participants
% of patients achieving PASI50 at Week 35 95.9 96.4 94.1 96.1
% of patients achieving PASI75 at Week 35 73.5 73.6 70.6 74.5
% of patients achieving PASI90 at Week 35 53.1 52.7 62.7 61.8
% of patients achieving PASI100 at Week 35 28.6 30.9 35.3 33.3
6.Secondary Outcome
Title PASI 50, PASI75, PASI 90 and PASI100 Response Rates
Hide Description Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)
Time Frame At Week 51 only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description:

Humira 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).

Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.

GP2017 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 Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).

GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Overall Number of Participants Analyzed 51 115 55 105
Measure Type: Number
Unit of Measure: percent of participants
% of patients achieving PASI50 at Week 51 95.3 93.9 87.5 95.9
% of patients achieving PASI75 at Week 51 76.7 79.6 75.0 84.5
% of patients achieving PASI90 at Week 51 48.8 51.0 60.4 62.9
% of patients achieving PASI100 at Week 51 25.6 29.6 31.3 35.1
7.Secondary Outcome
Title IGA Response Rate
Hide Description Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 17.
Time Frame At Week 17 only
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab
Hide Arm/Group Description:

Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

GP2017 Adalimumab

Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

Humira ® Adalimumab

Overall Number of Participants Analyzed 197 196
Measure Type: Number
Unit of Measure: percent of participants
53.6 53.6
8.Secondary Outcome
Title IGA Response Rate
Hide Description Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 51
Time Frame At Week 35 only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description:

Humira 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).

Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.

GP2017 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 Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).

GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Overall Number of Participants Analyzed 51 115 55 105
Measure Type: Number
Unit of Measure: percent of participants
59.2 58.2 58.8 58.8
9.Secondary Outcome
Title IGA Response Rate
Hide Description Proportion of patients achieving a score of 0 (“clear”) or 1 (“almost clear”) or improved by at least 2 points of the IGA scale compared to baseline at Week 51
Time Frame At Week 51 only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description:

Humira 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).

Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.

GP2017 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 Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).

GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Overall Number of Participants Analyzed 51 115 55 105
Measure Type: Number
Unit of Measure: percent of participants
46.5 55.1 58.3 59.8
10.Secondary Outcome
Title DLQI
Hide Description Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time Frame At Week 17 only
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 197 196
Measure Type: Number
Unit of Measure: % of patients with DLQI of 0 or 1
50.5 48.4
11.Secondary Outcome
Title DLQI
Hide Description Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time Frame At Week 35 only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description:

Humira 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).

Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.

GP2017 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 Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).

GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Overall Number of Participants Analyzed 51 115 55 105
Measure Type: Number
Unit of Measure: % of patients with DLQI of 0 or 1
49.0 54.5 52.9 55.9
12.Secondary Outcome
Title DLQI
Hide Description Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)
Time Frame At Week 51 only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description:

Humira 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).

Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.

GP2017 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 Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).

GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Overall Number of Participants Analyzed 51 115 55 105
Measure Type: Number
Unit of Measure: % of patients with DLQI of 0 or 1
48.8 55.6 54.2 59.8
13.Secondary Outcome
Title ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17
Hide Description

Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17.

Patients with ADA positive results at baseline were excluded from subsequent results.

Time Frame At Week 17 only
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.
Arm/Group Title GP2017 Adalimumab Humira ® Adalimumab
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 231 234
Measure Type: Number
Unit of Measure: % patients with at least 1 ADA+ sample
36.8 34.1
14.Secondary Outcome
Title ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51
Hide Description

Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51.

Patients with ADA positive results at baseline were excluded from subsequent results.

Time Frame At Week 51 only
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.
Arm/Group Title Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description:

Humira 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).

Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.

GP2017 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 Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).

GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
Overall Number of Participants Analyzed 63 127 63 126
Measure Type: Number
Unit of Measure: % patients with at least 1 ADA+ sample
39.3 45.1 46.7 35.8
Time Frame Treatment emergent adverse events (TEAEs) are reported from Day 1 until the end of study (Week 51)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Hide Arm/Group Description

Humira 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).

Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.

GP2017 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 Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).

GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).

GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
All-Cause Mortality
Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)      0/127 (0.00%)      0/63 (0.00%)      1/126 (0.79%)    
Show Serious Adverse Events Hide Serious Adverse Events
Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/63 (9.52%)      10/127 (7.87%)      2/63 (3.17%)      4/126 (3.17%)    
Cardiac disorders         
Cardiomyopathy  1  0/63 (0.00%)  0 0/127 (0.00%)  0 0/63 (0.00%)  0 1/126 (0.79%)  1
Coronary artery disease  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Gastrointestinal disorders         
Abdominall pain  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Vomiting  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
General disorders         
Chest pain  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Non-cardiac chest pain  1  1/63 (1.59%)  1 0/127 (0.00%)  0 0/63 (0.00%)  0 0/126 (0.00%)  0
Pyrexia  1  1/63 (1.59%)  1 0/127 (0.00%)  0 0/63 (0.00%)  0 0/126 (0.00%)  0
Swelling  1  1/63 (1.59%)  1 0/127 (0.00%)  0 0/63 (0.00%)  0 0/126 (0.00%)  0
Infections and infestations         
Pneumonia  1  2/63 (3.17%)  2 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Pneumonia necrotizing  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Pulmonary tuberculosis  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Pyelonephritis  1  0/63 (0.00%)  0 0/127 (0.00%)  0 0/63 (0.00%)  0 1/126 (0.79%)  1
Sepsis  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Joint effusion  1  1/63 (1.59%)  1 0/127 (0.00%)  0 0/63 (0.00%)  0 0/126 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal cell carcinoma  1  1/63 (1.59%)  1 1/127 (0.79%)  1 1/63 (1.59%)  1 1/126 (0.79%)  1
Adenocarcinoma of colon  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Chronic lymphocytic leukaemia  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Prostate cancer  1  0/63 (0.00%)  0 0/127 (0.00%)  0 1/63 (1.59%)  1 0/126 (0.00%)  0
Psychiatric disorders         
Completed suicide  1  0/63 (0.00%)  0 0/127 (0.00%)  0 0/63 (0.00%)  0 1/126 (0.79%)  1
Schizoaffective disorder  1  0/63 (0.00%)  0 0/127 (0.00%)  0 1/63 (1.59%)  1 0/126 (0.00%)  0
Suicide attempt  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Renal and urinary disorders         
Renal colic  1  1/63 (1.59%)  2 0/127 (0.00%)  0 0/63 (0.00%)  0 0/126 (0.00%)  0
Renal haematoma  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  0/63 (0.00%)  0 1/127 (0.79%)  1 0/63 (0.00%)  0 0/126 (0.00%)  0
1
Term from vocabulary, MedDRA version 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Humira ® Adalimumab Switched Humira ® Adalimumab Continued GP2017 Adalimumab Switched GP2017 Adalimumab Continued
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/63 (63.49%)      85/127 (66.93%)      47/63 (74.60%)      84/126 (66.67%)    
Blood and lymphatic system disorders         
Thrombocytopenia  1  0/63 (0.00%)  0 3/127 (2.36%)  5 2/63 (3.17%)  2 1/126 (0.79%)  1
Neutropenia  1  2/63 (3.17%)  2 1/127 (0.79%)  1 0/63 (0.00%)  0 1/126 (0.79%)  1
Gastrointestinal disorders         
Diarrhea  1  2/63 (3.17%)  2 7/127 (5.51%)  7 2/63 (3.17%)  2 2/126 (1.59%)  2
Toothache  1  0/63 (0.00%)  0 4/127 (3.15%)  5 3/63 (4.76%)  3 4/126 (3.17%)  4
Nausea  1  2/63 (3.17%)  3 4/127 (3.15%)  5 1/63 (1.59%)  1 3/126 (2.38%)  4
Dental caries  1  0/63 (0.00%)  0 5/127 (3.94%)  5 0/63 (0.00%)  0 2/126 (1.59%)  2
Constipation  1  1/63 (1.59%)  1 4/127 (3.15%)  6 0/63 (0.00%)  0 1/126 (0.79%)  1
Gastrooesophageal reflux disease  1  0/63 (0.00%)  0 4/127 (3.15%)  4 0/63 (0.00%)  0 0/126 (0.00%)  0
Abdominal discomfort  1  2/63 (3.17%)  2 0/127 (0.00%)  0 1/63 (1.59%)  1 0/126 (0.00%)  0
Food poisoning  1  0/63 (0.00%)  0 0/127 (0.00%)  0 2/63 (3.17%)  3 0/126 (0.00%)  0
General disorders         
Fatigue  1  1/63 (1.59%)  1 7/127 (5.51%)  8 4/63 (6.35%)  5 3/126 (2.38%)  3
Injection site erythema  1  0/63 (0.00%)  0 3/127 (2.36%)  3 5/63 (7.94%)  14 6/126 (4.76%)  8
Injection site bruising  1  2/63 (3.17%)  2 3/127 (2.36%)  3 0/63 (0.00%)  0 1/126 (0.79%)  1
Injection site pain  1  1/63 (1.59%)  1 2/127 (1.57%)  2 2/63 (3.17%)  15 1/126 (0.79%)  1
Injection site pruritus  1  1/63 (1.59%)  1 1/127 (0.79%)  2 2/63 (3.17%)  2 0/126 (0.00%)  0
Injection site induration  1  0/63 (0.00%)  0 0/127 (0.00%)  0 2/63 (3.17%)  2 0/126 (0.00%)  0
Immune system disorders         
Seasonal allergy  1  1/63 (1.59%)  2 5/127 (3.94%)  5 1/63 (1.59%)  1 4/126 (3.17%)  4
Infections and infestations         
Nasopharyngitis  1  7/63 (11.11%)  7 16/127 (12.60%)  17 8/63 (12.70%)  12 12/126 (9.52%)  23
Upper respiratory tract infection  1  5/63 (7.94%)  5 11/127 (8.66%)  14 3/63 (4.76%)  3 12/126 (9.52%)  17
Sinusitis  1  2/63 (3.17%)  2 7/127 (5.51%)  8 3/63 (4.76%)  3 11/126 (8.73%)  13
Bronchitis  1  3/63 (4.76%)  4 1/127 (0.79%)  1 2/63 (3.17%)  2 7/126 (5.56%)  7
Viral upper respiratory tract infection  1  2/63 (3.17%)  2 2/127 (1.57%)  2 3/63 (4.76%)  3 3/126 (2.38%)  4
Urinary tract infection  1  1/63 (1.59%)  1 2/127 (1.57%)  2 1/63 (1.59%)  1 5/126 (3.97%)  6
Gatroenteritis viral  1  2/63 (3.17%)  2 3/127 (2.36%)  3 2/63 (3.17%)  2 1/126 (0.79%)  1
Gastroenteritis  1  2/63 (3.17%)  2 2/127 (1.57%)  2 0/63 (0.00%)  0 2/126 (1.59%)  2
Influenza  1  2/63 (3.17%)  2 1/127 (0.79%)  1 2/63 (3.17%)  2 1/126 (0.79%)  1
Staphylococcal infection  1  1/63 (1.59%)  1 1/127 (0.79%)  1 2/63 (3.17%)  2 0/126 (0.00%)  0
Vulvovaginal mycotic infection  1  2/63 (3.17%)  3 1/127 (0.79%)  1 0/63 (0.00%)  0 1/126 (0.79%)  1
Injury, poisoning and procedural complications         
Muscle strain  1  3/63 (4.76%)  3 1/127 (0.79%)  1 1/63 (1.59%)  1 1/126 (0.79%)  1
Ligament sprain  1  2/63 (3.17%)  2 2/127 (1.57%)  2 0/63 (0.00%)  0 1/126 (0.79%)  1
Investigations         
Gamma-glutamyltransferase increased  1  0/63 (0.00%)  0 2/127 (1.57%)  2 4/63 (6.35%)  4 1/126 (0.79%)  1
Alanine aminotransferase increased  1  0/63 (0.00%)  0 2/127 (1.57%)  2 3/63 (4.76%)  3 0/126 (0.00%)  0
Weight decreased  1  1/63 (1.59%)  1 1/127 (0.79%)  1 2/63 (3.17%)  2 1/126 (0.79%)  1
Aspartate aminotransferase increased  1  0/63 (0.00%)  0 0/127 (0.00%)  0 3/63 (4.76%)  3 1/126 (0.79%)  1
Musculoskeletal and connective tissue disorders         
Arthralgia  1  3/63 (4.76%)  4 3/127 (2.36%)  4 6/63 (9.52%)  6 5/126 (3.97%)  8
Back pain  1  1/63 (1.59%)  1 5/127 (3.94%)  6 4/63 (6.35%)  4 5/126 (3.97%)  7
Pain in extremity  1  1/63 (1.59%)  1 2/127 (1.57%)  2 3/63 (4.76%)  4 2/126 (1.59%)  2
Musculoskeletal pain  1  2/63 (3.17%)  2 1/127 (0.79%)  1 0/63 (0.00%)  0 2/126 (1.59%)  2
Nervous system disorders         
Headache  1  7/63 (11.11%)  7 7/127 (5.51%)  8 2/63 (3.17%)  2 13/126 (10.32%)  20
Dizziness  1  0/63 (0.00%)  0 4/127 (3.15%)  4 0/63 (0.00%)  0 4/126 (3.17%)  4
Sciatica  1  2/63 (3.17%)  2 0/127 (0.00%)  0 0/63 (0.00%)  0 1/126 (0.79%)  1
Psychiatric disorders         
Anxiety  1  1/63 (1.59%)  1 3/127 (2.36%)  3 3/63 (4.76%)  3 1/126 (0.79%)  1
Insomnia  1  1/63 (1.59%)  1 4/127 (3.15%)  4 1/63 (1.59%)  1 1/126 (0.79%)  1
Respiratory, thoracic and mediastinal disorders         
Cough  1  4/63 (6.35%)  4 5/127 (3.94%)  5 1/63 (1.59%)  1 2/126 (1.59%)  3
Oropharyngeal pain  1  3/63 (4.76%)  3 3/127 (2.36%)  3 1/63 (1.59%)  1 2/126 (1.59%)  4
Sinus congestion  1  0/63 (0.00%)  0 4/127 (3.15%)  4 2/63 (3.17%)  2 2/126 (1.59%)  2
Rhinitis allergic  1  0/63 (0.00%)  0 1/127 (0.79%)  1 2/63 (3.17%)  2 0/126 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  0/63 (0.00%)  0 1/127 (0.79%)  1 2/63 (3.17%)  3 4/126 (3.17%)  6
Pruritus generalised  1  1/63 (1.59%)  1 4/127 (3.15%)  4 0/63 (0.00%)  0 0/126 (0.00%)  0
Urticaria  1  2/63 (3.17%)  2 2/127 (1.57%)  2 0/63 (0.00%)  0 0/126 (0.00%)  0
Dermal cyst  1  2/63 (3.17%)  2 0/127 (0.00%)  0 0/63 (0.00%)  0 0/126 (0.00%)  0
Dry skin  1  2/63 (3.17%)  2 0/127 (0.00%)  0 0/63 (0.00%)  0 0/126 (0.00%)  0
Psoriasis  1  2/63 (3.17%)  2 0/127 (0.00%)  0 0/63 (0.00%)  0 0/126 (0.00%)  0
Vascular disorders         
Hypertension  1  3/63 (4.76%)  3 10/127 (7.87%)  10 0/63 (0.00%)  0 2/126 (1.59%)  2
1
Term from vocabulary, MedDRA version 19.0
Indicates events were collected by systematic assessment
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Global Program Medical Director
Organization: Sandoz
Phone: +49 8024 476 ext 0
EMail: biopharma.clinicaltrials@sandoz.com
Layout table for additonal information
Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT02016105     History of Changes
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