search
Back to results

A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tocilizumab SC
tocilizumab IV
placebo to tocilizumab SC
placebo to tocilizumab IV
Disease-modifying antirheumatic drugs (DMARDs)
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult participants, ≥ 18 years of age
  • Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
  • Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
  • Inadequate response to current DMARD therapy
  • Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
  • Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
  • Rheumatic autoimmune disease other than RA
  • Functional class IV (ACR classification)
  • Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
  • Prior history of or current inflammatory joint disease other than RA
  • Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
  • Previous treatment with tocilizumab
  • Active current or history of recurrent infection

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tocilizumab SC

Tocilizumab IV

Tocilizumab SC Then Tocilizumab IV

Tocilizumab IV Then Tocilizumab SC

Arm Description

Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.

Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.

Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.

Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24
ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]).
Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments

Secondary Outcome Measures

Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24
ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24
ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24
The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.
Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24
The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.
Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97
ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97
The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.
Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97
The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.
Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion
Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment
Minimum Serum Concentration (Cmin) of Tocilizumab
Maximum Serum Concentration (Cmax) of Tocilizumab
Time to Maximum Serum Concentration (Tmax) of Tocilizumab
Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25
Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97
Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97

Full Information

First Posted
September 1, 2010
Last Updated
May 11, 2016
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT01194414
Brief Title
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
Official Title
A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1262 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab SC
Arm Type
Experimental
Arm Description
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Arm Title
Tocilizumab IV
Arm Type
Experimental
Arm Description
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Arm Title
Tocilizumab SC Then Tocilizumab IV
Arm Type
Experimental
Arm Description
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
Arm Title
Tocilizumab IV Then Tocilizumab SC
Arm Type
Experimental
Arm Description
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period. Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
Intervention Type
Drug
Intervention Name(s)
tocilizumab SC
Other Intervention Name(s)
RoActemra/Actemra
Intervention Description
Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.
Intervention Type
Drug
Intervention Name(s)
tocilizumab IV
Other Intervention Name(s)
RoActemra/Actemra
Intervention Description
Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo to tocilizumab SC
Intervention Description
Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.
Intervention Type
Drug
Intervention Name(s)
placebo to tocilizumab IV
Intervention Description
Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Intervention Type
Drug
Intervention Name(s)
Disease-modifying antirheumatic drugs (DMARDs)
Intervention Description
stable dose as prescribed
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24
Description
ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]).
Time Frame
Baseline, 24 weeks
Title
Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments
Time Frame
Baseline to up to 3 months after last dose of study drug (approximately up to 2 years)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24
Description
ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).
Time Frame
Baseline, 24 weeks
Title
Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24
Description
ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate).
Time Frame
Baseline, 24 weeks
Title
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24
Description
The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6.
Time Frame
Week 24
Title
Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
Description
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a participant completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement.
Time Frame
Baseline, 24 Weeks
Title
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24
Description
The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.
Time Frame
24 Weeks
Title
Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97
Description
ACR20, ACR50 and ACR70: ≥20%, ≥50% and ≥70% reduction from baseline for both TJC68 and SJC66, as well as for 3 of 5 additional ACR variables: Patient's Assessment of Pain in last 24 hours using a Visual Analog Scale (VAS) (0=no pain and 100=unbearable pain); Patient's and Physician's Global Assessment of Disease Activity in last 24 hours using a VAS (0=no disease activity and100=maximum disease activity); Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either CRP or ESR). CRP was used for calculation of ACR. If missing, ESR was used. LOCF was used for missing joint counts, no imputation for other ACR components.
Time Frame
Week 97
Title
Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97
Description
The DAS28 (ESR) score is a measure of the subject's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity VAS where left side of the line 0=no disease activity to right side of the line 100=extreme disease activity and ESR. DAS28-(ESR) total scores range from 0 - 10. Remission is defined as achieving a DAS28-ESR score of less than 2.6. LOCF used for tender and swollen joint counts, no imputation used for ESR and Patient's Global Assessment of Disease Activity VAS.
Time Frame
Week 97
Title
Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97
Description
The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A decrease indicates improvement. No imputation of missing scores was made other than for missing baseline scores, for which last score prior to baseline will be carried forward. For participants who prematurely withdrew, data collected at withdrawal visit was used and data thereafter is missing.
Time Frame
Baseline, Week 97
Title
Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97
Description
The percentage of participants who withdrew from the study because they were not responding to treatment with the study drug.
Time Frame
Week 97
Title
Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion
Time Frame
Week 0: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after first dose
Title
Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment
Time Frame
Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose.
Title
Minimum Serum Concentration (Cmin) of Tocilizumab
Time Frame
Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Title
Maximum Serum Concentration (Cmax) of Tocilizumab
Time Frame
Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Title
Time to Maximum Serum Concentration (Tmax) of Tocilizumab
Time Frame
Week 0, Week 20: at 6 hours (hr), 24 hr, 48 hr, 96 hr, 120 hr and 168 hr after dose
Title
Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25
Time Frame
Baseline, Week 25
Title
Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97
Time Frame
Baseline, Week 97
Title
Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97
Time Frame
Week 97

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult participants, ≥ 18 years of age Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline Inadequate response to current DMARD therapy Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline Exclusion Criteria: Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization Rheumatic autoimmune disease other than RA Functional class IV (ACR classification) Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16 Prior history of or current inflammatory joint disease other than RA Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline Previous treatment with tocilizumab Active current or history of recurrent infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230-7127
Country
United States
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Coeur D'alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
City
St. Claire Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
City
Manalapan
State/Province
New Jersey
ZIP/Postal Code
07726
Country
United States
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
City
Buenos Aires
ZIP/Postal Code
B1878DVB
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1428DQG
Country
Argentina
City
Rosario
ZIP/Postal Code
S2000PBJ
Country
Argentina
City
Adelaide
ZIP/Postal Code
5011
Country
Australia
City
Adelaide
ZIP/Postal Code
5041
Country
Australia
City
Clayton
ZIP/Postal Code
3168
Country
Australia
City
Geelong
ZIP/Postal Code
3220
Country
Australia
City
Hobart
ZIP/Postal Code
7000
Country
Australia
City
Malvern East
ZIP/Postal Code
3145
Country
Australia
City
Maroochydore
ZIP/Postal Code
4558
Country
Australia
City
New Lambton
ZIP/Postal Code
2305
Country
Australia
City
Curitiba
ZIP/Postal Code
80060-240
Country
Brazil
City
Goiania
ZIP/Postal Code
74110010
Country
Brazil
City
Juiz de Fora
ZIP/Postal Code
36010-570
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04039-000
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
4037003
Country
Brazil
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L7
Country
Canada
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2N 7E4
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 3W1
Country
Canada
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
City
Barranquilla
Country
Colombia
City
Bogota
Country
Colombia
City
Bogotá
Country
Colombia
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Le Mans
ZIP/Postal Code
72037
Country
France
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nantes
ZIP/Postal Code
44035
Country
France
City
Paris
ZIP/Postal Code
75679
Country
France
City
Strasbourg
ZIP/Postal Code
67098
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Bad Bramstedt
ZIP/Postal Code
24576
Country
Germany
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
14059
Country
Germany
City
Dresden
ZIP/Postal Code
01067
Country
Germany
City
Essen
ZIP/Postal Code
45239
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Gommern
ZIP/Postal Code
39245
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Herne
ZIP/Postal Code
44652
Country
Germany
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
City
Köln
ZIP/Postal Code
50924
Country
Germany
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
City
Rostock
ZIP/Postal Code
18059
Country
Germany
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Arenzano
ZIP/Postal Code
16011
Country
Italy
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Catania
ZIP/Postal Code
95124
Country
Italy
City
Cona (ferrara)
ZIP/Postal Code
44124
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Pisa
ZIP/Postal Code
56100
Country
Italy
City
Potenza
ZIP/Postal Code
85100
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
City
Culiacan
ZIP/Postal Code
80000
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44629
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44690
Country
Mexico
City
Leon
ZIP/Postal Code
37000
Country
Mexico
City
Merida
ZIP/Postal Code
97000
Country
Mexico
City
Mexico Ctiy
ZIP/Postal Code
07760
Country
Mexico
City
Miexico City
ZIP/Postal Code
06700
Country
Mexico
City
Morelia
ZIP/Postal Code
58070
Country
Mexico
City
Obregon
ZIP/Postal Code
85000
Country
Mexico
City
Queretaro
ZIP/Postal Code
76178
Country
Mexico
City
Saltillo
ZIP/Postal Code
25000
Country
Mexico
City
Torreon
ZIP/Postal Code
27000
Country
Mexico
City
Auckland
ZIP/Postal Code
2025
Country
New Zealand
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
City
Wellington
ZIP/Postal Code
6035
Country
New Zealand
City
Lima 01
ZIP/Postal Code
01
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 14
Country
Peru
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
City
Manila
ZIP/Postal Code
1000
Country
Philippines
City
Quezon
ZIP/Postal Code
1102
Country
Philippines
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
City
Warszawa
ZIP/Postal Code
01-157
Country
Poland
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
City
Bucharest
ZIP/Postal Code
011172
Country
Romania
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
City
Bucuresti
ZIP/Postal Code
020983
Country
Romania
City
Iasi
ZIP/Postal Code
700661
Country
Romania
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
City
Ulyanovsk
ZIP/Postal Code
432600
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
City
Durban
ZIP/Postal Code
4001
Country
South Africa
City
Parktown
ZIP/Postal Code
2000
Country
South Africa
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Merida
ZIP/Postal Code
97500
Country
Spain
City
Santander
ZIP/Postal Code
39008
Country
Spain
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Torrelavega
ZIP/Postal Code
39300
Country
Spain
City
Valencia
ZIP/Postal Code
46009
Country
Spain
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
Cannock
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
City
Eastbourne
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
City
Harrogate
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
City
Westcliffe-on-sea
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26056119
Citation
Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016 Jan;75(1):68-74. doi: 10.1136/annrheumdis-2015-207281. Epub 2015 Jun 8.
Results Reference
derived

Learn more about this trial

A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis

We'll reach out to this number within 24 hrs