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GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

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ClinicalTrials.gov Identifier: NCT01274182
Recruitment Status : Completed
First Posted : January 11, 2011
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
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: Rheumatoid Arthritis
Interventions: Biological: GP2013
Biological: MabThera
Biological: Rituxan

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
GP2013 GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
MabThera MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Rituxan Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)

Participant Flow:   Overall Study
    GP2013   MabThera   Rituxan
STARTED   133   87   92 
24 Weeks   123   83   84 
COMPLETED   112   69   80 
NOT COMPLETED   21   18   12 
Unsatisfactory therapeutic effect                6                3                4 
Adverse Event                4                5                3 
Withdrawal by Subject                5                5                3 
Lost to Follow-up                2                3                1 
Protocol Violation                3                2                0 
Death                1                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set

Reporting Groups
  Description
GP2013 GP2013: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
MabThera MabThera: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Rituxan Rituxan: 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Total Total of all reporting groups

Baseline Measures
   GP2013   MabThera   Rituxan   Total 
Overall Participants Analyzed 
[Units: Participants]
 133   87   92   312 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed   133   87   92   312 
   54.42  (11.779)   52.17  (12.531)   54.95  (10.750)   54.10  (11.701) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed   133   87   92   312 
Female      111  83.5%      73  83.9%      78  84.8%      262  84.0% 
Male      22  16.5%      14  16.1%      14  15.2%      50  16.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Participants Analyzed   133   87   92   312 
American Indian or Alaska Native      0   0.0%      1   1.1%      0   0.0%      1   0.3% 
Asian      12   9.0%      12  13.8%      0   0.0%      24   7.7% 
Native Hawaiian or Other Pacific Islander      1   0.8%      0   0.0%      0   0.0%      1   0.3% 
Black or African American      1   0.8%      6   6.9%      6   6.5%      13   4.2% 
White      117  88.0%      68  78.2%      75  81.5%      260  83.3% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      2   1.5%      0   0.0%      11  12.0%      13   4.2% 
Region of Enrollment 
[Units: Participants]
       
Argentina         
Participants Analyzed   133   87   92   312 
Argentina   8   3   9   20 
Austria         
Participants Analyzed   133   87   92   312 
Austria   7   10   3   20 
Turkey         
Participants Analyzed   133   87   92   312 
Turkey   4   1   2   7 
Romania         
Participants Analyzed   133   87   92   312 
Romania   9   8   6   23 
Belgium         
Participants Analyzed   133   87   92   312 
Belgium   1   4   0   5 
United States         
Participants Analyzed   133   87   92   312 
United States   10   0   19   29 
Brazil         
Participants Analyzed   133   87   92   312 
Brazil   19   12   19   50 
Italy         
Participants Analyzed   133   87   92   312 
Italy   5   3   3   11 
France         
Participants Analyzed   133   87   92   312 
France   4   1   0   5 
Germany         
Participants Analyzed   133   87   92   312 
Germany   31   17   14   62 
India         
Participants Analyzed   133   87   92   312 
India   12   12   0   24 
Spain         
Participants Analyzed   133   87   92   312 
Spain   13   16   4   33 
Russia         
Participants Analyzed   133   87   92   312 
Russia   6   0   11   17 
Hungary         
Participants Analyzed   133   87   92   312 
Hungary   3   0   1   4 
Estonia         
Participants Analyzed   133   87   92   312 
Estonia   1   0   1   2 
Body Mass Index (BMI) [1] 
[Units: Kg/m2]
Mean (Standard Deviation)
       
Participants Analyzed   133   85   92   310 
   27.37  (6.230)   27.25  (6.000)   29.66  (6.606)   28.02  (6.353) 
Duration of Rheumatoid Arthritis(RA) [1] [2] 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed   133   86   92   311 
   10.53  (8.074)   10.81  (7.137)   11.10  (8.299)   10.78  (7.874) 
Number of patients having received 1, 2 or >2 TNF inhibitor therapies. 
[Units: Participants]
Count of Participants
       
Participants Analyzed   133   87   92   312 
    109  82.0%      70  80.5%      73  79.3%      252  80.8% 
    18  13.5%      16  18.4%      13  14.1%      47  15.1% 
>2      6   4.5%      1   1.1%      6   6.5%      13   4.2% 
Disease Activity Score 28 joint count - C-reactive proteine (DAS28-CRP) [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Participants Analyzed   132   87   91   310 
   5.83  (0.922)   5.85  (0.880)   5.91  (1.009)   5.86  (0.935) 
Dose of methotrexate at baseline [1] 
[Units: Mg/week]
Mean (Standard Deviation)
       
Participants Analyzed   131   84   91   306 
   15.09  (4.856)   14.65  (5.154)   15.29  (4.888)   15.03  (4.939) 
Anti-drug antibodies (ADA) 
[Units: Participants]
Count of Participants
       
Participants Analyzed   133   87   92   312 
Negative      132  99.2%      85  97.7%      87  94.6%      304  97.4% 
Positive      0   0.0%      2   2.3%      3   3.3%      5   1.6% 
Missing      1   0.8%      0   0.0%      2   2.2%      3   1.0% 


  Outcome Measures

1.  Primary:   AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA   [ Time Frame: From baseline to 24 weeks ]

2.  Secondary:   Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA   [ Time Frame: From baseline to week 24 ]

3.  Secondary:   Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA   [ Time Frame: 14 days ]

4.  Secondary:   Change From Baseline in DAS28(CRP) at Week 24   [ Time Frame: 24 weeks ]

5.  Secondary:   Number of Patients With ACR20 (CRP) Response   [ Time Frame: 24 weeks ]

6.  Secondary:   Summary of Disease Activity According to CDAI   [ Time Frame: At week 24 ]

7.  Secondary:   Summary of Disease Activity According to SDAI   [ Time Frame: At week 24 ]

8.  Secondary:   Participant Response as Assessed by EULAR Response Criteria   [ Time Frame: At week 24 ]

9.  Other Pre-specified:   Number of Patients With at Least One Anti-Drug-Antibody (ADA) Positive Serum Sample   [ Time Frame: through study completion, an average of 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Program Medical Director
Organization: Sandoz
phone: +49 8024 476 ext 0
e-mail: biopharma.clinicaltrials@sandoz.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01274182     History of Changes
Other Study ID Numbers: GP13-201
2010-021184-32 ( EudraCT Number )
GPN013A2301 ( Other Identifier: Novartis )
First Submitted: January 10, 2011
First Posted: January 11, 2011
Results First Submitted: November 9, 2017
Results First Posted: January 24, 2018
Last Update Posted: January 24, 2018