Back to resultsA Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tocilizumab
Methotrexate
Non-Biologic DMARDs
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
- Moderate to severe RA with a DAS28-ESR score >3.2 points
- Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
- Oral corticosteroids (less than or equal to [</=] 10 mg per day prednisolone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline
- Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
- Receiving treatment on an outpatient basis, not including tocilizumab
- Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
- Rheumatic autoimmune disease other than RA
- Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
- Prior history of or current inflammatory joint disease other than RA
- Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Evidence of serious concomitant disease or disorder
- Known active current or history of recurrent infection
- Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for hepatitis B or hepatitis C
- History of or current active primary or secondary immunodeficiency
- Pregnant or lactating women
- Neuropathies or other conditions that might interfere with pain evaluation
- Inadequate hematologic, renal, or liver function
Sites / Locations
- Aalborg Universitetshospital Nord, Reumatologisk Afdeling
- Glostrup Hospital, Reumatologisk Afdeling, Ambulatoriet
- Gentofte Hospital, Medicinsk Afd. C, Klinik for Gigt- og Rygsygdomme
- Holbæk Sygehus, Medicinsk Afd., Reumatologisk Amb.15-2
- Sjællands Universitetshospital, Køge; Reumatologisk Afdeling
- Odense Universitetshospital, Reumatologisk Afdeling C, Ambulatoriet
- Svendborg Sygehus, Reumatologisk Ambulatorium
- Helsinki University Central Hospital; Rheumatology Clinic
- Kiljavan Lääketutkimus Oy
- Central Hospital of Pohjois-Karjala; Outpatient Clinic of Rheumatology
- Keski-Suomen Keskussairaala; Sisätautien Klinikka
- Lappeenranta Central Hospital; Outpatient Clinic of Internal Medicine
- Oulu University Hospital; Rheumatology
- Haukeland Universitetssykehus; Revmatologisk Avdeling
- Drammen sykehus Vestre Viken HF, Revmatologisk avd.
- Diakonhjemmet; Reumatolgisk Avdeling
- St. Olavs Hospital; Revmatologisk avdeling
- Ålesund Sykehus; Revmatologisk Avdeling
- Länssjukhuset Ryhov; Ortoped- och Reumatolog kliniken
- Uni Hospital Linkoeping; Dept. of Rheumatology
- Skånes Universitetssjukhus Lund; Reumatologkliniken
- Skånes Universitetssjukhus Malmö; Reumatologkliniken
- Örebro Uni Hospital; Rheumatology
- Simrishamns Sjukhus
- Karolinska Sjukhuset; Reumatologkliniken D2-1
- Akademiska sjukhuset, Reumatologkliniken
- Västmanlands sjukhus Västerås, Reumatologkliniken
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tocilizumab Alone or Combined with Methotrexate or Other DMARD
Arm Description
All participants will receive tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs, irrespective of body weight, for 24 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12
CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Secondary Outcome Measures
Change From Baseline in Disease Activity Score 28 (DAS28)-Erythrocyte Sedimentation Rate (ESR) Score
DAS28-ESR was based on TJC, SJC, PGA of disease activity, and laboratory-derived ESR. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. The total DAS28-ESR score was transformed to a single score range of 0-10, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Percentage of Participants With American College of Rheumatology (ACR) Response
ACR response was assessed on the basis of percent improvement (20% for ACR20, 50% for ACR50, 70% for ACR70) in both TJC and SJC as well as at least three of the following: physician assessment of disease activity, PGA of disease activity, PGA of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either ESR or C-reactive protein level. TJC and SJC were taken as the number of tender and swollen joints, out of 68 and 66 assessed joints, respectively. PGA and physician assessments were scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity or pain. HAQ-DI was scored using participant responses to 20 questions assessing activities of daily living (ADLs), with total score scale of 0-3, where higher scores indicate increased functional disability. The percentage of participants meeting criteria for each level of ACR response was reported.
Percentage of Participants With European League Against Rheumatism (EULAR) Response
EULAR response was assessed by change from baseline and absolute DAS28-ESR score. EULAR response classification was as follows: Good (change >1.2 with absolute score </=3.2), Moderate (change >1.2 with absolute score >3.2 or change >0.6 with absolute score </=5.1), None (change </=0.6 or absolute score >5.1). DAS28-ESR was based on TJC, SJC, and PGA of disease activity, and laboratory-derived ESR. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. The total DAS28-ESR score was transformed to a single score range of 0-10, where higher scores indicate increased disease activity. The percentage of participants meeting criteria for each level of EULAR response was reported.
Change From Baseline in CDAI at Weeks 2, 4, 8, 16, 20, and 24
CDAI was derived as the sum of the following: TJC, SJC, PGA of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 mm and rounded to the nearest cm on a VAS, where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Change From Baseline in Simplified Disease Activity Index (SDAI)
SDAI was derived as the sum of the following: TJC, SJC, PGA of disease activity, physician assessment of disease activity, and laboratory-derived C-reactive protein level. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 mm and rounded to the nearest cm on a VAS, where higher scores indicate greater perceived disease activity. The total SDAI score range was 0-86, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Change From Baseline in TJC
TJC was taken as the number of tender joints out of 28 assessed joints.
Change From Baseline in SJC
SJC was taken as the number of swollen joints out of 28 assessed joints.
Percentage of Participants With At Least One Adverse Event Leading to Dosage Modification
The percentage of participants with at least one adverse event leading to dose/frequency reduction or temporary dose hold was reported.
Number of Participants With Neutralizing Anti-Tocilizumab Antibodies
Participants were evaluated for the presence of anti-tocilizumab antibodies. Confirmatory assays were performed in the case of a positive screen assay result.
Tocilizumab Concentration
Tocilizumab concentration was determined, averaged among all participants, and expressed in micrograms per milliliter (mcg/mL).
Soluble Interleukin-6 Receptor (sIL-6R) Concentration
sIL-6R concentration was determined, averaged among all participants, and expressed in nanograms per milliliter (ng/mL).
Change From Baseline in Patient Global Assessment of Disease Activity According to VAS
PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Change From Baseline in Patient Global Assessment of RA-Related Pain According to VAS
PGA of RA-related pain was scored 0-100 mm on a VAS, where higher scores indicate greater perceived pain. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA-related pain.
Change From Baseline in HAQ-DI Score
HAQ-DI consisted of 20 questions assessing ADLs in 8 domains (dress/groom, arise, eat, walk, reach, grip, hygiene) with each item rated 0 (no difficulty) to 3 (unable to do). The highest score recorded for any question in a domain determined the score for that domain, unless assistance was required. The total HAQ-DI score was the sum of domain scores divided by the number of domains answered/scored, for a single score range of 0-3, where higher scores indicate increased functional disability. Change from baseline was averaged among all participants. Negative values indicate improvement in ability to perform ADLs.
Compliance With Treatment According to Percentage of Injections Administered
Participants were provided with diary cards to record home injections. Compliance with treatment was calculated individually for each participant as the actual number of injections as a percentage of the planned number of injections (up to the point of discontinuation for those who discontinued study treatment prematurely) and then averaged among all participants.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
FACIT-F consisted of 40 questions/statements assessing chronic illness therapy with special emphasis on fatigue over the past 7 days, with each item rated 0 (not at all) to 4 (very much). During score calculations, negatively-worded item scales (e.g., "I have a lack of energy") were reversed so that higher scores indicated more favorable conditions. The total FACIT-F score was the sum of all item scores and ranged 0-160, and the brief FACIT-F score was the sum of 13 item scores and ranged 0-52, where higher scores indicate greater well-being. Change from baseline was averaged among all participants. Positive values indicate improvement in well-being.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02046616
Brief Title
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Official Title
Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 28, 2014 (Actual)
Primary Completion Date
September 13, 2016 (Actual)
Study Completion Date
September 13, 2016 (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 Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab Alone or Combined with Methotrexate or Other DMARD
Arm Type
Experimental
Arm Description
All participants will receive tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs, irrespective of body weight, for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
RoActemra, Actemra
Intervention Description
Tocilizumab 162 mg will be administered subcutaneously QW.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.
Intervention Type
Drug
Intervention Name(s)
Non-Biologic DMARDs
Intervention Description
Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.
Primary Outcome Measure Information:
Title
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12
Description
CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score 28 (DAS28)-Erythrocyte Sedimentation Rate (ESR) Score
Description
DAS28-ESR was based on TJC, SJC, PGA of disease activity, and laboratory-derived ESR. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. The total DAS28-ESR score was transformed to a single score range of 0-10, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24
Title
Percentage of Participants With American College of Rheumatology (ACR) Response
Description
ACR response was assessed on the basis of percent improvement (20% for ACR20, 50% for ACR50, 70% for ACR70) in both TJC and SJC as well as at least three of the following: physician assessment of disease activity, PGA of disease activity, PGA of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either ESR or C-reactive protein level. TJC and SJC were taken as the number of tender and swollen joints, out of 68 and 66 assessed joints, respectively. PGA and physician assessments were scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity or pain. HAQ-DI was scored using participant responses to 20 questions assessing activities of daily living (ADLs), with total score scale of 0-3, where higher scores indicate increased functional disability. The percentage of participants meeting criteria for each level of ACR response was reported.
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 24
Title
Percentage of Participants With European League Against Rheumatism (EULAR) Response
Description
EULAR response was assessed by change from baseline and absolute DAS28-ESR score. EULAR response classification was as follows: Good (change >1.2 with absolute score </=3.2), Moderate (change >1.2 with absolute score >3.2 or change >0.6 with absolute score </=5.1), None (change </=0.6 or absolute score >5.1). DAS28-ESR was based on TJC, SJC, and PGA of disease activity, and laboratory-derived ESR. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. The total DAS28-ESR score was transformed to a single score range of 0-10, where higher scores indicate increased disease activity. The percentage of participants meeting criteria for each level of EULAR response was reported.
Time Frame
Weeks 2, 4, 8, 12, 16, 20, 24
Title
Change From Baseline in CDAI at Weeks 2, 4, 8, 16, 20, and 24
Description
CDAI was derived as the sum of the following: TJC, SJC, PGA of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 mm and rounded to the nearest cm on a VAS, where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Time Frame
Baseline and Weeks 2, 4, 8, 16, 20, 24
Title
Change From Baseline in Simplified Disease Activity Index (SDAI)
Description
SDAI was derived as the sum of the following: TJC, SJC, PGA of disease activity, physician assessment of disease activity, and laboratory-derived C-reactive protein level. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 mm and rounded to the nearest cm on a VAS, where higher scores indicate greater perceived disease activity. The total SDAI score range was 0-86, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24
Title
Change From Baseline in TJC
Description
TJC was taken as the number of tender joints out of 28 assessed joints.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24
Title
Change From Baseline in SJC
Description
SJC was taken as the number of swollen joints out of 28 assessed joints.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24
Title
Percentage of Participants With At Least One Adverse Event Leading to Dosage Modification
Description
The percentage of participants with at least one adverse event leading to dose/frequency reduction or temporary dose hold was reported.
Time Frame
Baseline up to Week 24
Title
Number of Participants With Neutralizing Anti-Tocilizumab Antibodies
Description
Participants were evaluated for the presence of anti-tocilizumab antibodies. Confirmatory assays were performed in the case of a positive screen assay result.
Time Frame
Baseline to FU Week 8 (up to 32 weeks overall)
Title
Tocilizumab Concentration
Description
Tocilizumab concentration was determined, averaged among all participants, and expressed in micrograms per milliliter (mcg/mL).
Time Frame
Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)
Title
Soluble Interleukin-6 Receptor (sIL-6R) Concentration
Description
sIL-6R concentration was determined, averaged among all participants, and expressed in nanograms per milliliter (ng/mL).
Time Frame
Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)
Title
Change From Baseline in Patient Global Assessment of Disease Activity According to VAS
Description
PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24
Title
Change From Baseline in Patient Global Assessment of RA-Related Pain According to VAS
Description
PGA of RA-related pain was scored 0-100 mm on a VAS, where higher scores indicate greater perceived pain. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA-related pain.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24
Title
Change From Baseline in HAQ-DI Score
Description
HAQ-DI consisted of 20 questions assessing ADLs in 8 domains (dress/groom, arise, eat, walk, reach, grip, hygiene) with each item rated 0 (no difficulty) to 3 (unable to do). The highest score recorded for any question in a domain determined the score for that domain, unless assistance was required. The total HAQ-DI score was the sum of domain scores divided by the number of domains answered/scored, for a single score range of 0-3, where higher scores indicate increased functional disability. Change from baseline was averaged among all participants. Negative values indicate improvement in ability to perform ADLs.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24
Title
Compliance With Treatment According to Percentage of Injections Administered
Description
Participants were provided with diary cards to record home injections. Compliance with treatment was calculated individually for each participant as the actual number of injections as a percentage of the planned number of injections (up to the point of discontinuation for those who discontinued study treatment prematurely) and then averaged among all participants.
Time Frame
Baseline up to Week 24
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score
Description
FACIT-F consisted of 40 questions/statements assessing chronic illness therapy with special emphasis on fatigue over the past 7 days, with each item rated 0 (not at all) to 4 (very much). During score calculations, negatively-worded item scales (e.g., "I have a lack of energy") were reversed so that higher scores indicated more favorable conditions. The total FACIT-F score was the sum of all item scores and ranged 0-160, and the brief FACIT-F score was the sum of 13 item scores and ranged 0-52, where higher scores indicate greater well-being. Change from baseline was averaged among all participants. Positive values indicate improvement in well-being.
Time Frame
Baseline and Weeks 2, 4, 8, 12, 16, 20, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
Moderate to severe RA with a DAS28-ESR score >3.2 points
Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
Oral corticosteroids (less than or equal to [</=] 10 mg per day prednisolone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline
Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
Receiving treatment on an outpatient basis, not including tocilizumab
Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
Exclusion Criteria:
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
Rheumatic autoimmune disease other than RA
Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
Prior history of or current inflammatory joint disease other than RA
Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline
Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Evidence of serious concomitant disease or disorder
Known active current or history of recurrent infection
Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
Active tuberculosis requiring treatment within the previous 3 years
Positive for hepatitis B or hepatitis C
History of or current active primary or secondary immunodeficiency
Pregnant or lactating women
Neuropathies or other conditions that might interfere with pain evaluation
Inadequate hematologic, renal, or liver function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Aalborg Universitetshospital Nord, Reumatologisk Afdeling
City
Alborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Glostrup Hospital, Reumatologisk Afdeling, Ambulatoriet
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Gentofte Hospital, Medicinsk Afd. C, Klinik for Gigt- og Rygsygdomme
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Holbæk Sygehus, Medicinsk Afd., Reumatologisk Amb.15-2
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Facility Name
Sjællands Universitetshospital, Køge; Reumatologisk Afdeling
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Odense Universitetshospital, Reumatologisk Afdeling C, Ambulatoriet
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Svendborg Sygehus, Reumatologisk Ambulatorium
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Helsinki University Central Hospital; Rheumatology Clinic
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Kiljavan Lääketutkimus Oy
City
Hyvinkää
ZIP/Postal Code
05800
Country
Finland
Facility Name
Central Hospital of Pohjois-Karjala; Outpatient Clinic of Rheumatology
City
Joensuu
ZIP/Postal Code
80210
Country
Finland
Facility Name
Keski-Suomen Keskussairaala; Sisätautien Klinikka
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Facility Name
Lappeenranta Central Hospital; Outpatient Clinic of Internal Medicine
City
Lappeenranta
ZIP/Postal Code
53130
Country
Finland
Facility Name
Oulu University Hospital; Rheumatology
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Haukeland Universitetssykehus; Revmatologisk Avdeling
City
Bergen
ZIP/Postal Code
5053
Country
Norway
Facility Name
Drammen sykehus Vestre Viken HF, Revmatologisk avd.
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Facility Name
Diakonhjemmet; Reumatolgisk Avdeling
City
Oslo
ZIP/Postal Code
0370
Country
Norway
Facility Name
St. Olavs Hospital; Revmatologisk avdeling
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Facility Name
Ålesund Sykehus; Revmatologisk Avdeling
City
Ålesund
ZIP/Postal Code
6017
Country
Norway
Facility Name
Länssjukhuset Ryhov; Ortoped- och Reumatolog kliniken
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Uni Hospital Linkoeping; Dept. of Rheumatology
City
Linkoeping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Skånes Universitetssjukhus Lund; Reumatologkliniken
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Skånes Universitetssjukhus Malmö; Reumatologkliniken
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Örebro Uni Hospital; Rheumatology
City
Oerebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Simrishamns Sjukhus
City
Simrishamn
ZIP/Postal Code
272 81
Country
Sweden
Facility Name
Karolinska Sjukhuset; Reumatologkliniken D2-1
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Akademiska sjukhuset, Reumatologkliniken
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Västmanlands sjukhus Västerås, Reumatologkliniken
City
Västerås
ZIP/Postal Code
72189
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
34131623
Citation
Hammer HB, Jensen Hansen IM, Jarvinen P, Leirisalo-Repo M, Ziegelasch M, Agular B, Terslev L. Rheumatoid arthritis patients with predominantly tender joints rarely achieve clinical remission despite being in ultrasound remission. Rheumatol Adv Pract. 2021 May 14;5(2):rkab030. doi: 10.1093/rap/rkab030. eCollection 2021.
Results Reference
derived
PubMed Identifier
33464147
Citation
Hammer HB, Hansen I, Jarvinen P, Leirisalo-Repo M, Ziegelasch M, Agular B, Terslev L. Major reduction of ultrasound-detected synovitis during subcutaneous tocilizumab treatment: results from a multicentre 24 week study of patients with rheumatoid arthritis. Scand J Rheumatol. 2021 Jul;50(4):262-270. doi: 10.1080/03009742.2020.1845394. Epub 2021 Jan 19.
Results Reference
derived
PubMed Identifier
30649524
Citation
Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.
Results Reference
derived
PubMed Identifier
29244149
Citation
Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443. Erratum In: Rheumatology (Oxford). 2018 Jun 1;57(6):1129.
Results Reference
derived
Learn more about this trial
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
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