- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01063062
A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)
July 17, 2017 updated by: Hoffmann-La Roche
A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)
This single-arm, open-label, multicenter study evaluated the safety and tolerability and the efficacy in reducing disease activity of tocilizumab [RoActemra/Actemra] as monotherapy or in combination with methotrexate in patients with active moderate to severe rheumatoid arthritis (RA).
Patients were eligible to participate in this study if they are currently experiencing an inadequate response to a stable dose of a non-biologic disease-modifying antirheumatic drug (DMARD).
Patients received 8 mg/kg tocilizumab [RoActemra/Actemra] as an intravenous infusion every 4 weeks for a total of 6 infusions.
The anticipated time on study treatment was 24 weeks.
The target sample size was 50-200 patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
107
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alexandria, Egypt
- Alexandria University
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Alexandria, Egypt
- Alexandria University Hospital; Rheumatology
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Banha, Egypt
- Banha Educational Hospital; Rheumatology
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Cairo, Egypt
- Kasr el ainy hospital
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Cairo, Egypt, 11562
- Kasr El Ainy Hospital; Rheumatology
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Cairo, Egypt
- Ain Shams University Hospital; Rheumatology
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Cairo, Egypt
- Bab El Sheereya Hospital; Rheumatology
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Cairo, Egypt
- El Hussein University Hospital; Rheumatology
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Cairo, Egypt
- Manial Specialized Hospital; Rheumatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients ≥ 18 years of age
- Moderate to severe rheumatoid arthritis (RA) for at least 6 months (defined as a Disease Activity Score (DAS28) > 3.2 at screening)
- Patients with active RA after more than 12 weeks of treatment with DMARDs
- Patients with inadequate response to a stable dose of non-biologic DMARD
Exclusion Criteria:
- Autoimmune disease other than RA. Patients with interstitial pulmonary fibrosis and able to tolerate methotrexate (MTX) and patients with Sjögren's Syndrome and RA are permitted
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Prior history of or current inflammatory joint disease other than RA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tocilizumab
Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
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8 mg/kg intravenous infusion every 4 weeks.
methotrexate as per standard of care in clinical practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity
Time Frame: Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)
|
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
Low Disease Activity was defined as a DAS28 score of < 3.2.
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Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24)
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Time to DAS28 Low Disease Activity
Time Frame: 24 Weeks
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Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score <3.2 units.
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
Low Disease Activity was defined as a DAS28 score of < 3.2.
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24 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving DAS28 Clinically Significant Improvement
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24
|
DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline.
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
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Baseline, Weeks 4, 8, 12, 16, 20, 24
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Time to DAS28 Clinically Significant Improvement
Time Frame: 24 Weeks
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Time to DAS28 Clinically Significant Improvement was the Time in days from the first infusion of study drug to the achievement of a DAS28 score reduction of at least 1.2 units.
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
Low Disease Activity was defined as a DAS28 score of < 3.2.
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24 Weeks
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Percentage of Participants Achieving DAS28 Remission
Time Frame: Weeks 4, 8, 12, 16, 20, 24
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DAS28 Remission was defined as a DAS28 score < 2.6 units.
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
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Weeks 4, 8, 12, 16, 20, 24
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Time to DAS28 Remission
Time Frame: 24 Weeks
|
Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units.
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
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24 Weeks
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Disease Activity Score 28 (DAS28)
Time Frame: Weeks 4, 8, 12, 16, 20, 24
|
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10.
Low Disease Activity was defined as a DAS28 score of < 3.2.
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Weeks 4, 8, 12, 16, 20, 24
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C-Reactive Protein (CRP)
Time Frame: Weeks 4, 8, 12, 16, 20, 24
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Blood was collected for C-Reactive Protein (CRP), a test for inflammation, at Weeks 4, 8, 12, 16, 20 and 24 and was analyzed at a central laboratory.
The serum concentration of CRP was measured in milligrams/deciliter (mg/dL).
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Weeks 4, 8, 12, 16, 20, 24
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Erythrocyte Sedimentation Rate (ESR)
Time Frame: Weeks 4, 8, 12, 16, 20, 24
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Blood was collected for Erythrocyte Sedimentation Rate (ESR), a test to assess inflammation, at Weeks 4, 8, 12, 16, 20, 24 and was analyzed at a central laboratory.
ESR was measured in millimeters/hour (mm/hr).
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Weeks 4, 8, 12, 16, 20, 24
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 24 Weeks
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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24 Weeks
|
Number of Participants With AE and SAE Related Discontinuation
Time Frame: 24 Weeks
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The number of participants who stopped using the study drug because of an AE or a SAE.
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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24 Weeks
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Number of Participants With Serious Infections
Time Frame: 24 Weeks
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A serious infection was an infection that qualified as a Serious Adverse Event (SAE).
A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
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24 Weeks
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Number of Participants With Elevated AST (SGOT) and ALT (SGPT)
Time Frame: Week 24
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Blood was collected for aspartate aminotransferase (serum glutamic oxaloacetic transaminase) [AST/SGOT] and alanine aminotransferase (serum glutamic pyruvic transaminase) [ALT/SGPT], liver function tests, and were analyzed at a central laboratory.
The number of participants with High AST (SGOT) or ALT (SGPT) levels at Week 24 is reported.
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Week 24
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Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines
Time Frame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
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Blood samples were collected for Total Cholesterol and were sent to a central laboratory for analysis.
According to Adult Treatment Profile III (ATPIII) guidelines the Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Desirable ( < 200), Borderline High (200- 239) or High (≥ 240).
The number of participants categorized Borderline High or High at each time-point is reported.
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Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
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Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines
Time Frame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
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Blood samples were collected for High Density Lipoprotein (HDL) Cholesterol and were sent to a central laboratory for analysis.
According to Adult Treatment Profile III (ATPIII) guidelines the HDL Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Low (< 40) or High (≥ 60).
The number of participants with category High at each time-point is reported.
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Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
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Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines
Time Frame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
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Blood samples were collected for Low Density Lipoprotein (LDL) Cholesterol and were sent to a central laboratory for analysis.
According to Adult Treatment Profile III (ATPIII) guidelines the LDL Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Optimal (< 100), Near Optimal/Above Optimal (100- 129), Borderline High (130- 159), High (160-189) or Very High (≥ 190).
The number of participants categorized Borderline High, High or Very High at each time-point is reported.
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Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
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Number of Participants With Elevated Triglyceride According to ATPIII Guidelines
Time Frame: Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
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Blood samples were collected for Triglyceride and were sent to a central laboratory for analysis.
According to Adult Treatment Profile III (ATPIII) guidelines the Triglyceride level in milligram/deciliter (mg/dL) was categorized as: Normal (< 150), Borderline High (150- 199), High (200- 499) or Very High (≥ 500).
The number of participants categorized Borderline High, High or Very High at each time-point is reported.
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Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2010
Primary Completion (Actual)
January 17, 2011
Study Completion (Actual)
January 17, 2011
Study Registration Dates
First Submitted
February 3, 2010
First Submitted That Met QC Criteria
February 3, 2010
First Posted (Estimate)
February 5, 2010
Study Record Updates
Last Update Posted (Actual)
August 21, 2017
Last Update Submitted That Met QC Criteria
July 17, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- ML22725
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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