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Trial record 46 of 72 for:    Peru | Panama

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01007435
Recruitment Status : Completed
First Posted : November 4, 2009
Results First Posted : July 12, 2013
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Tocilizumab
Drug: Placebo to tocilizumab
Drug: Methotrexate
Drug: Placebo to methotrexate

  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
Five of 1162 randomized patients (2 placebo to tocilizumab + methotrexate, 2 tocilizumab 4 mg/kg + methotrexate, 1 tocilizumab 8 mg/kg + methotrexate) did not receive any study treatment and were excluded from all analysis populations.

Reporting Groups
  Description
Placebo to Tocilizumab + Methotrexate Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
Tocilizumab 4 mg/kg + Methotrexate Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Tocilizumab 8 mg/kg + Methotrexate Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Tocilizumab 8 mg/kg + Placebo to Methotrexate Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.

Participant Flow:   Overall Study
    Placebo to Tocilizumab + Methotrexate   Tocilizumab 4 mg/kg + Methotrexate   Tocilizumab 8 mg/kg + Methotrexate   Tocilizumab 8 mg/kg + Placebo to Methotrexate
STARTED   289   290   291   292 
COMPLETED   226   231   227   236 
NOT COMPLETED   63   59   64   56 
Adverse Event                16                25                47                31 
Death                2                4                2                1 
Insufficient Therapeutic Response                21                7                2                9 
Violation of Selection Criteria at Entry                3                5                2                0 
Other Protocol Violation                2                0                1                0 
Refused Treatment                13                13                5                8 
Failure to Return                5                4                3                6 
Reason not Specified                1                1                2                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.
Baseline Characteristics were based on the intent-to-treat (ITT) population. Five of 1162 randomized patients (2 placebo + methotrexate, 2 tocilizumab 4 mg/kg + methotrexate, 1 tocilizumab 8 mg/kg + methotrexate) did not receive any study treatment and were excluded from all analysis populations. The ITT population therefore included 1157 patients.

Reporting Groups
  Description
Placebo to Tocilizumab + Methotrexate Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
Tocilizumab 4 mg/kg + Methotrexate Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Tocilizumab 8 mg/kg + Methotrexate Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
Tocilizumab 8 mg/kg + Placebo to Methotrexate Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo to Tocilizumab + Methotrexate   Tocilizumab 4 mg/kg + Methotrexate   Tocilizumab 8 mg/kg + Methotrexate   Tocilizumab 8 mg/kg + Placebo to Methotrexate   Total 
Overall Participants Analyzed 
[Units: Participants]
 287   288   290   292   1157 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.6  (13.10)   51.2  (13.84)   49.5  (13.70)   49.9  (13.22)   50.1  (13.47) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      229  79.8%      228  79.2%      228  78.6%      219  75.0%      904  78.1% 
Male      58  20.2%      60  20.8%      62  21.4%      73  25.0%      253  21.9% 


  Outcome Measures

1.  Primary:   Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 52   [ Time Frame: Week 52 ]

3.  Secondary:   Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52   [ Time Frame: Baseline to Weeks 24 and 52 ]

4.  Secondary:   Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52   [ Time Frame: Baseline to Week 52 ]

5.  Secondary:   Change From Baseline in Modified Sharp Erosion Score at Week 52   [ Time Frame: Baseline to Week 52 ]

6.  Secondary:   Change From Baseline in Sharp Joint Space Narrowing Score at Week 52   [ Time Frame: Baseline to Week 52 ]

7.  Secondary:   Percentage of Participants With a Major Clinical Response at Week 52   [ Time Frame: Baseline to Week 52 ]

8.  Secondary:   Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Weeks 24 and 52   [ Time Frame: Baseline to Weeks 24 and 52 ]

9.  Secondary:   Change From Baseline in Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at Weeks 24 and 52   [ Time Frame: Baseline to Weeks 24 and 52 ]


  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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01007435     History of Changes
Other Study ID Numbers: WA19926
2009-012759-12
First Submitted: November 3, 2009
First Posted: November 4, 2009
Results First Submitted: May 23, 2013
Results First Posted: July 12, 2013
Last Update Posted: July 26, 2017