Back to resultsA Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Methotrexate (stable dose)
Tocilizumab
Methotrexate (tapering dose)
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Active severe rheumatoid arthritis (DAS28 > 5.1) according to European League of Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
- Inadequate response to a trial of 2 DMARDs, including methotrexate, a trial being defined as 6 months with 2 months at standard dose; no previous treatment with a biologic agent such as a tumor necrosis factor (TNF) inhibitor
- Oral corticosteroids must have been at a stable dose of </= 10 mg/day prednisolone or equivalent for at least 25 out of 28 days prior to start of treatment (Day 1)
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 rheumatoid arthritis
- Functional class IV as defined by the ACR Classification of Functional Status in RA
- Prior history of or current inflammatory joint disease other than RA
- Previous treatment with tocilizumab
- Previous treatment with any biologic drug (e.g. TNF inhibitor) that is used in the treatment of RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to enrollment
- Inadequate liver, bone marrow or hepatic function
- Positive for hepatitis B, hepatitis C or HIV infection
- Pregnant or breastfeeding women
- Females of child-bearing potential who are not using reliable means of contraception
- History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
- Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
- History of, or currently active, primary or secondary immunodeficiency
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methotrexate (MTX) Tapering Dosage
Methotrexate (MTX) Maintenance Dosage
Arm Description
At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks. At Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response will be randomized to the MTX Tapering group or MTX Maintenance group. In this arm participants will receive a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. Participants will also continue to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants will receive tocilizumab monotherapy.
At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks. At Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response will be randomized to the MTX Tapering group or MTX Maintenance group. In this arm participants will continue to be administered a stable dose of MTX in a double-blind fashion between Week 24 and Week 56. Participants will also continue to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants will receive tocilizumab monotherapy.
Outcomes
Primary Outcome Measures
Percentage of Participants Maintaining Previous Disease Activity (European League Against Rheumatism [EULAR] Response) From Week 24 (Time of Randomization) to Week 60
Response was determined using EULAR criteria based upon (Disease Activity Score In 28 Joints) DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (<=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'
Secondary Outcome Measures
Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 60
The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 72
The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Percentage of Participants Who Achieve Score of <=1 in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 60 and 72
Percentage of participants who achieve score of =1 in TJC and SJC at week 60 and 72 were reported. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.
Percentage of Participants Who Achieve a Disease Activity Score In 28 Joints (DAS28) <= 3.2
The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve score <=3.2 at weeks 60 and 72 were reported.
Percentage of Participants Who Achieve DAS28 Remission (DAS28 < 2.6)
The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve DAS28 remission score <2.6 at weeks 60 and 72 were reported.
Percentage of Participants Who Achieve Change in Disease Activity Score (cDAS) >=1.2
The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve cDAS28 >=1.2 score at weeks 60 and 72 were reported.
Percentage of Participants Who Achieve Clinical Disease Activity Index (CDAI) Remission (CDAI < 2.8) at Week 60 and 72
Clinical Disease Activity Index (CDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + patient global assessment of disease (PGA) 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity.
Percentage of Participants Who Achieve Simplified Disease Activity Index (SDAI) Remission (SDAI < 3.3) at Week 60 and 72
Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity.
Percentage of Participants With Improvement in Physical Function Using Health Assessment Questionnaire [HAQ] at Week 60 and 72
The HAQ-disability index (DI) evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of participants with an improvement in HAQ-DI score.
Percentage of Participants With Improvement in Physical Function Using Functional Assessment of Chronic Illness Therapy - Fatigue [FACIT-F] at Week 60 and 72
The FACIT-fatigue assessment was a 13-item questionnaire with participants scoring each item on a 5-point scale (not at all; a little bit; somewhat; quite a bit and very much). The total score ranges from 0 to 65 and higher scores indicate more fatigue. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in total FACIT score.
Percentage of Participants With Improvement in Physical Function Using 12-item Short Form Health Survey [SF-12]) at Week 60 and 72
Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in SF-12 score.
Percentage of Participants With Anemia
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any adverse event that can be fatal, life threatening, requires long or prolong hospitalization, results in persistent or significant disability/incapacity, congenital anomaly or significant medical event in the investigator's judgment.
Percentage of Participants Able to Discontinue Methotrexate
Number of Subjects Employed Assessed Using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities.
Hours Actually Worked and Work Hours Missed Assessed Using the WPAI-SHP
The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Reported here are hours actually worked, work hours missed due to rheumatoid arthritis (RA), work hours missed due to other reasons and the change from Week 24 for each of these parameters reported at Week 60 and Week 72.
Change in Productivity and Regular Daily Activities Affected by Rheumatoid Arthritis Assessed Using the WPAI-SHP
The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Assessments were made using a visual analogue scale ranging from 0 to 10 where 0 = minimum impact and 10 = maximum impact.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01661140
Brief Title
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage
Official Title
Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (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, placebo-controlled, double-blind study will compare the safety and efficacy of tapering methotrexate (MTX) versus maintaining MTX dosage in patients with severe active rheumatoid arthritis and an inadequate response to disease-modifying antirheumatic drugs (DMARDs) initiated on treatment with tocilizumab. Participants will receive tocilizumab 8 mg/kg intravenously every 4 weeks and MTX orally weekly throughout the study. At Week 24, participants achieving a good/moderate EULAR response will be randomized receiving the MTX Tapering arm or MTX Maintenance arm. Up to Week 56 participants will receive either tapering or stable dose MTX in combination with tocilizumab. From Week 56 to Week 72 participants will receive tocilizumab monotherapy.
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 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
427 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methotrexate (MTX) Tapering Dosage
Arm Type
Experimental
Arm Description
At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks. At Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response will be randomized to the MTX Tapering group or MTX Maintenance group. In this arm participants will receive a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. Participants will also continue to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants will receive tocilizumab monotherapy.
Arm Title
Methotrexate (MTX) Maintenance Dosage
Arm Type
Active Comparator
Arm Description
At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks. At Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response will be randomized to the MTX Tapering group or MTX Maintenance group. In this arm participants will continue to be administered a stable dose of MTX in a double-blind fashion between Week 24 and Week 56. Participants will also continue to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants will receive tocilizumab monotherapy.
Intervention Type
Drug
Intervention Name(s)
Methotrexate (stable dose)
Intervention Description
Methotrexate (MTX) was administered weekly according to the subject's pre-study MTX dose
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
RoActemra/Actemra
Intervention Description
8 mg/kg intravenously every 4 weeks for 72 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate (tapering dose)
Intervention Description
Tapering doses of methotrexate (MTX) were administered weekly from Week 24 to Week 56. Tapering doses depended on dose administered to the subject during the open label period. First tapering occurred at randomization (Week 24), second tapering at Week 32, third tapering at Week 40 and final tapering at Week 48.
Primary Outcome Measure Information:
Title
Percentage of Participants Maintaining Previous Disease Activity (European League Against Rheumatism [EULAR] Response) From Week 24 (Time of Randomization) to Week 60
Description
Response was determined using EULAR criteria based upon (Disease Activity Score In 28 Joints) DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (<=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'
Time Frame
From randomization to Week 60
Secondary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 60
Description
The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Time Frame
Randomization (Week 24), Week 60
Title
Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 72
Description
The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Time Frame
Randomization (Week 24), Week 72
Title
Percentage of Participants Who Achieve Score of <=1 in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 60 and 72
Description
Percentage of participants who achieve score of =1 in TJC and SJC at week 60 and 72 were reported. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.
Time Frame
Week 60, 72
Title
Percentage of Participants Who Achieve a Disease Activity Score In 28 Joints (DAS28) <= 3.2
Description
The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve score <=3.2 at weeks 60 and 72 were reported.
Time Frame
Week 60, 72
Title
Percentage of Participants Who Achieve DAS28 Remission (DAS28 < 2.6)
Description
The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve DAS28 remission score <2.6 at weeks 60 and 72 were reported.
Time Frame
Week 60, 72
Title
Percentage of Participants Who Achieve Change in Disease Activity Score (cDAS) >=1.2
Description
The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve cDAS28 >=1.2 score at weeks 60 and 72 were reported.
Time Frame
Week 60, 72
Title
Percentage of Participants Who Achieve Clinical Disease Activity Index (CDAI) Remission (CDAI < 2.8) at Week 60 and 72
Description
Clinical Disease Activity Index (CDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + patient global assessment of disease (PGA) 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity.
Time Frame
Randomization (Week 24), Week 60, 72
Title
Percentage of Participants Who Achieve Simplified Disease Activity Index (SDAI) Remission (SDAI < 3.3) at Week 60 and 72
Description
Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity.
Time Frame
Randomization (Week 24), Week 60, 72
Title
Percentage of Participants With Improvement in Physical Function Using Health Assessment Questionnaire [HAQ] at Week 60 and 72
Description
The HAQ-disability index (DI) evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of participants with an improvement in HAQ-DI score.
Time Frame
Randomization (Week 24), Week 60, 72
Title
Percentage of Participants With Improvement in Physical Function Using Functional Assessment of Chronic Illness Therapy - Fatigue [FACIT-F] at Week 60 and 72
Description
The FACIT-fatigue assessment was a 13-item questionnaire with participants scoring each item on a 5-point scale (not at all; a little bit; somewhat; quite a bit and very much). The total score ranges from 0 to 65 and higher scores indicate more fatigue. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in total FACIT score.
Time Frame
Randomization (Week 24), Week 60, 72
Title
Percentage of Participants With Improvement in Physical Function Using 12-item Short Form Health Survey [SF-12]) at Week 60 and 72
Description
Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in SF-12 score.
Time Frame
Randomization (Week 24), Week 60, 72
Title
Percentage of Participants With Anemia
Time Frame
Week 0 up to Week 72
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any adverse event that can be fatal, life threatening, requires long or prolong hospitalization, results in persistent or significant disability/incapacity, congenital anomaly or significant medical event in the investigator's judgment.
Time Frame
Week 0 up to Week 72
Title
Percentage of Participants Able to Discontinue Methotrexate
Time Frame
Week 0 up to Week 60
Title
Number of Subjects Employed Assessed Using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)
Description
The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities.
Time Frame
Randomization (Week 24), Week 60, 72
Title
Hours Actually Worked and Work Hours Missed Assessed Using the WPAI-SHP
Description
The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Reported here are hours actually worked, work hours missed due to rheumatoid arthritis (RA), work hours missed due to other reasons and the change from Week 24 for each of these parameters reported at Week 60 and Week 72.
Time Frame
Randomization (Week 24), Week 60, Week 72
Title
Change in Productivity and Regular Daily Activities Affected by Rheumatoid Arthritis Assessed Using the WPAI-SHP
Description
The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Assessments were made using a visual analogue scale ranging from 0 to 10 where 0 = minimum impact and 10 = maximum impact.
Time Frame
Randomization (Week 24), Week 60, 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/= 18 years of age
Active severe rheumatoid arthritis (DAS28 > 5.1) according to European League of Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
Inadequate response to a trial of 2 DMARDs, including methotrexate, a trial being defined as 6 months with 2 months at standard dose; no previous treatment with a biologic agent such as a tumor necrosis factor (TNF) inhibitor
Oral corticosteroids must have been at a stable dose of </= 10 mg/day prednisolone or equivalent for at least 25 out of 28 days prior to start of treatment (Day 1)
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 rheumatoid arthritis
Functional class IV as defined by the ACR Classification of Functional Status in RA
Prior history of or current inflammatory joint disease other than RA
Previous treatment with tocilizumab
Previous treatment with any biologic drug (e.g. TNF inhibitor) that is used in the treatment of RA
Intraarticular or parenteral corticosteroids within 6 weeks prior to enrollment
Inadequate liver, bone marrow or hepatic function
Positive for hepatitis B, hepatitis C or HIV infection
Pregnant or breastfeeding women
Females of child-bearing potential who are not using reliable means of contraception
History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
History of, or currently active, primary or secondary immunodeficiency
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
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
City
Abergavenny
ZIP/Postal Code
NP7 7EG
Country
United Kingdom
City
Ashford
ZIP/Postal Code
TW15 3AA
Country
United Kingdom
City
Aylesbury
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
City
Bournemouth
ZIP/Postal Code
BH23 2JX
Country
United Kingdom
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
City
Bury St Edmonds
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
Cannock
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
City
Crewe
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
City
Darlington
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
City
Dundee
ZIP/Postal Code
DD12 9SY
Country
United Kingdom
City
Eastbourne
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
City
Greenock
ZIP/Postal Code
PA16 0XN
Country
United Kingdom
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
City
Harrogate
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
City
Hull
ZIP/Postal Code
HU3 3JZ
Country
United Kingdom
City
Isle of Wight
ZIP/Postal Code
PO30 5TG
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
City
Llantrisant
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
City
London
ZIP/Postal Code
SE18 4QH
Country
United Kingdom
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M13 9PT
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M41 5SL
Country
United Kingdom
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
North Shields
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
City
Northampton
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
City
Oldham
ZIP/Postal Code
OL1 1NL
Country
United Kingdom
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
City
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Southport
ZIP/Postal Code
PR8 6PN
Country
United Kingdom
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
City
Stoke-on-trent
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
City
Sutton in Ashfield
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
City
Walsall
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
City
Warwick
ZIP/Postal Code
CV34 5BW
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
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
City
Worthing
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
City
Wrightington
ZIP/Postal Code
WN6 9EP
Country
United Kingdom
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage
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