A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01119859
First received: April 1, 2010
Last updated: January 10, 2013
Last verified: January 2013
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Results First Received: September 18, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment |
| Condition: |
Rheumatoid Arthritis |
| Interventions: |
Drug: Tocilizumab Drug: Adalimumab Drug: Placebo to tocilizumab Drug: Placebo to adalimumab |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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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 | |
|---|---|
| Tocilizumab 8 mg/kg | Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. |
| Adalimumab 40 mg | Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks. |
Participant Flow: Overall Study
| Tocilizumab 8 mg/kg | Adalimumab 40 mg | |
|---|---|---|
| STARTED | 163 | 163 |
| COMPLETED | 139 | 133 |
| NOT COMPLETED | 24 | 30 |
| Adverse Event | 9 | 10 |
| Death | 2 | 0 |
| Insufficient therapeutic response | 7 | 14 |
| Refused treatment | 3 | 6 |
| Failure to return | 3 | 0 |
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. |
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Reporting Groups
| Description | |
|---|---|
| Tocilizumab 8 mg/kg | Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. |
| Adalimumab 40 mg | Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks. |
| Total | Total of all reporting groups |
Baseline Measures
| Tocilizumab 8 mg/kg | Adalimumab 40 mg | Total | |
|---|---|---|---|
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Number of Participants
[units: participants] |
163 | 162 | 325 |
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Age
[1] [units: years] Mean ± Standard Deviation |
54.4 ± 12.95 | 53.3 ± 12.43 | 53.9 ± 12.67 |
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Gender
[1] [units: participants] |
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| Female | 129 | 133 | 262 |
| Male | 34 | 29 | 63 |
| [1] | Baseline Characteristics were analyzed for the intent-to-treat (ITT) population which included all randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. One randomized patient in the adalimumab treatment group did not receive treatment and was not included in any of the data analyses, including demographics. |
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Outcome Measures
Show All Outcome Measures
| 1. Primary: | Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) [ Time Frame: Baseline to Week 24 ] |
| 2. Secondary: | Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24 [ Time Frame: Week 24 ] |
Hide Outcome Measure 2
| Measure Type | Secondary |
|---|---|
| Measure Title | Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24 |
| Measure Description | The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported. |
| Time Frame | Week 24 |
| Safety Issue | No |
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. |
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| Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. |
Reporting Groups
| Description | |
|---|---|
| Tocilizumab 8 mg/kg | Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. |
| Adalimumab 40 mg | Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks. |
Measured Values
| Tocilizumab 8 mg/kg | Adalimumab 40 mg | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
163 | 162 |
|
Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
[units: Percentage of patients] |
39.9 | 10.5 |
No statistical analysis provided for Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
| 3. Secondary: | Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24 [ Time Frame: Week 24 ] |
| 4. Secondary: | Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24 [ Time Frame: Baseline to Week 24 ] |
| 5. Secondary: | Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24 [ Time Frame: Baseline to Week 24 ] |
| 6. Secondary: | Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 [ Time Frame: Baseline to Week 24 ] |
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 |
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