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A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01645280
First received: June 6, 2012
Last updated: December 12, 2014
Last verified: December 2014
Results First Received: December 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Rheumatoid
Interventions: Drug: Placebo + methotrexate (MTX) (Group 1)
Drug: Ustekinumab + MTX (Group 2)
Drug: Ustekinumab + MTX (Group 3)
Drug: CNTO 1959 + MTX (Group 4)
Drug: CNTO 1959 + MTX (Group 5)

  Participant Flow
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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
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Reporting Groups
  Description
Placebo Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Ustekinumab 90 mg Every 8 Weeks Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Ustekinumab 90 mg Every 12 Weeks Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
CNTO1959 200 mg Every 8 Weeks Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
CNTO1959 50 mg Every 8 Weeks Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.

Participant Flow:   Overall Study
    Placebo     Ustekinumab 90 mg Every 8 Weeks     Ustekinumab 90 mg Every 12 Weeks     CNTO1959 200 mg Every 8 Weeks     CNTO1959 50 mg Every 8 Weeks  
STARTED     55     55     55     54     55  
Treated     55     54     55     54     55  
COMPLETED     49     51     49     48     47  
NOT COMPLETED     6     4     6     6     8  
Death                 0                 1                 0                 0                 0  
Withdrawal by Subject                 4                 0                 2                 4                 5  
Lost to Follow-up                 0                 0                 0                 2                 1  
Unspecified                 1                 1                 2                 0                 0  
Treatment not completed/Completed f/u                 1                 2                 2                 0                 2  



  Baseline Characteristics
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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.
Analysis population included all randomized participants.

Reporting Groups
  Description
Placebo Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Ustekinumab 90 mg Every 8 Weeks Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Ustekinumab 90 mg Every 12 Weeks Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
CNTO1959 200 mg Every 8 Weeks Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
CNTO1959 50 mg Every 8 Weeks Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
Total Total of all reporting groups

Baseline Measures
    Placebo     Ustekinumab 90 mg Every 8 Weeks     Ustekinumab 90 mg Every 12 Weeks     CNTO1959 200 mg Every 8 Weeks     CNTO1959 50 mg Every 8 Weeks     Total  
Number of Participants  
[units: participants]
  55     55     55     54     55     274  
Age  
[units: years]
Mean ± Standard Deviation
  51.1  ± 10.57     50.8  ± 13.01     51.4  ± 13.59     54.6  ± 11.34     49.9  ± 12.85     51.5  ± 12.34  
Gender  
[units: participants]
           
Female     48     46     47     42     45     228  
Male     7     9     8     12     10     46  
Region of Enrollment  
[units: participants]
           
Argentina     1     5     6     5     6     23  
Bulgaria     2     2     2     2     1     9  
CZ Rep     0     0     1     0     0     1  
Chile     1     1     1     1     2     6  
Colombia     10     9     8     6     10     43  
Hungary     6     5     2     4     3     20  
Poland     5     8     6     7     9     35  
Russia     20     15     18     19     14     86  
Singapore     1     1     0     2     0     4  
USA     0     0     1     0     0     1  
Ukraine     9     9     10     8     10     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28   [ Time Frame: Week 28 ]

2.  Secondary:   Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28   [ Time Frame: From Baseline to Week 28 ]

3.  Secondary:   Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12   [ Time Frame: Week 12 ]

4.  Secondary:   Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28   [ Time Frame: Baseline and Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Senior Director Clin Development
Organization: Janssen Pharmaceuticals
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01645280     History of Changes
Other Study ID Numbers: CR100736, CNTO1275ARA2001, 2011-001122-18
Study First Received: June 6, 2012
Results First Received: December 12, 2014
Last Updated: December 12, 2014
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
Turkey: Ministry of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines