TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF
2014年9月15日 更新者:Hoffmann-La Roche
Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO
This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF.
For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo.
After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks.
Methotrexate or DMARD therapy will be continued throughout study treatment.
Target sample size is >100.
調査の概要
研究の種類
介入
入学 (実際)
103
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Amiens、フランス、80054
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Amiens、フランス、80094
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Bayonne、フランス、64109
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Bois Guillaume、フランス、76233
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Bordeaux、フランス、33076
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Brest、フランス、29609
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Cahors、フランス、46005
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Chambray Les Tours、フランス、37171
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Clermont-ferrand、フランス、63003
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Echirolles、フランス、38434
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La Roche Sur Yon、フランス、85925
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Limoges、フランス、87042
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Lyon、フランス、69437
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Metz、フランス、57077
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Nantes、フランス、44035
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Orleans、フランス、45000
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Paris、フランス、75651
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Paris、フランス、75679
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Paris、フランス、75877
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Rennes、フランス、35203
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St Priest En Jarez、フランス、42277
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Toulouse、フランス、31059
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- adult patients >/= 18 years of age
- active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF
- on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose
- patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks
Exclusion Criteria:
- rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- functional class IV by ACR classification
- history of inflammatory joint disease other than RA
- previous treatment with cell-depleting therapies, abatacept or rituximab
- active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:1
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single iv infusion 8 mg/kg
iv infusion 8mg/kg every 4 weeks for 11 months
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プラセボコンパレーター:2
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単回静脈内注入
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実験的:3
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single iv infusion 8 mg/kg
iv infusion 8mg/kg every 4 weeks for 11 months
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4
時間枠:Week 4
|
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity.
To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen.
Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.
Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.
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Week 4
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period
時間枠:Baseline, Weeks 1 and 4
|
Participants were asked to rate their assessment of disease activity using a visual analog scale (VAS) of 0 to 100 millimeters (mm), where 0 represented no symptoms and 100 represented severe symptoms.
Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
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Baseline, Weeks 1 and 4
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Patient Global Assessment of Disease Activity During the Open Treatment Period
時間枠:Baseline, Weeks 12, 24, 36 and 48
|
Participants were asked to rate their assessment of disease activity using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms.
Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
|
Baseline, Weeks 12, 24, 36 and 48
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Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period
時間枠:Baseline and Week 4
|
Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms.
Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
|
Baseline and Week 4
|
Physician Global Assessment of Disease Activity During the Open Treatment Period
時間枠:Baseline, Weeks 12, 24, 36, and 48
|
Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms.
Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
|
Baseline, Weeks 12, 24, 36, and 48
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Patient Global Assessment of Pain During the Double-Blind Treatment Period
時間枠:Baseline and Week 4
|
Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain.
Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
|
Baseline and Week 4
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Patient Global Assessment of Pain During the Open Treatment Period
時間枠:Baseline and Weeks 12, 24, 36, and 48
|
Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain.
Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured.
A negative value in change from Baseline indicates an improvement.
|
Baseline and Weeks 12, 24, 36, and 48
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Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound
時間枠:Baseline, Weeks 1 and 4
|
Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 metacarpal phalangeal [MCP; left and right] joints, 5 proximal interphalangeal [PIP; left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 metatarsal phalangeal [MTP; left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120.
A score of 0 indicated no damage and a score of 120 indicated most severe damage.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. A negative change from baseline indicated improvement.
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Baseline, Weeks 1 and 4
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Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound
時間枠:Baseline, Weeks 1 and 4
|
Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Negative change from baseline indicated improvement.
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound
時間枠:Weeks 12, 24, and 48
|
Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage (%) change from baseline.
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Weeks 12, 24, and 48
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Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound
時間枠:Weeks 12, 24, and 48
|
Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP [left and right] joints, 5 PIP [left and right] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage change from baseline.
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Weeks 12, 24, and 48
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Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period
時間枠:Baseline, Weeks 1 and 4
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Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm per hour (mm/hr).
A reduction in ESR indicates improvement.
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment
時間枠:Weeks 1 and 4
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Erythrocyte sedimentation rate is a biological marker of inflammation.
A negative change indicates improvement.
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Weeks 1 and 4
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Erythrocyte Sedimentation Rate During the Open Treatment Period
時間枠:Baseline, Weeks 12, 24, 36, and 48
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Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm/hr.
A reduction in ESR indicates improvement.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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C-Reactive Protein During the Double-Blind Treatment Period
時間枠:Baseline, Weeks 1 and 4
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C-Reactive protein (CRP) is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL).
A reduction in CRP indicates improvement.
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period
時間枠:Weeks 1 and 4
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C-Reactive protein (CRP) is a biological marker of inflammation.
Negative changes from baseline indicate improvement.
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Weeks 1 and 4
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C- Reactive Protein During the Open Treatment Period
時間枠:Baseline, Weeks 12, 24, 36, and 48
|
C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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Serum Amyloid A Component During the Double-Blind Treatment Period
時間枠:Baseline, Weeks 1 and 4
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Serum Amyloid A (SAA) component is a biological marker of inflammation and is measured in mg/L.
A reduction in SAA indicates improvement.
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Baseline, Weeks 1 and 4
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Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period
時間枠:Weeks 1 and 4
|
Serum Amyloid A (SAA) component is a biological marker of inflammation.
A negative change from baseline indicates improvement.
|
Weeks 1 and 4
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Serum Amyloid A Component During the Open Treatment Period
時間枠:Baseline, Weeks 12, 24, 36, and 48
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Serum Amyloid A (SAA) component is a biological marker of inflammation measured in mg/L.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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Beta 2 Microglobulin Levels During the Open Treatment Period
時間枠:Baseline, Weeks 12, 24, 36, and 48
|
Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
|
Baseline, Weeks 12, 24, 36, and 48
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Beta 2 Microglobulin Levels During the Double-Blind Treatment Period
時間枠:Baseline, Weeks 1 and 4
|
Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).
|
Baseline, Weeks 1 and 4
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Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period
時間枠:Weeks 1 and 4
|
Beta 2 Microglobulin is a biological marker of inflammation.
If baseline value was equal to 0, it was replaced by 0.1 to calculate the change from baseline.
|
Weeks 1 and 4
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Bone Mineral Density
時間枠:Baseline and Week 48
|
To describe bone mineral density (BMD), standardized values were calculated for lumbar spine, hip, femoral neck, and trochanter, taking into account the type of Dual energy X ray absorptiometry (DXA) used.
All DXA at baseline were taken into account (done from before screening to Week 8).
DXA at end of study were taken into account if they were done after at least 6 infusions of tocilizumab.
Values were measured in milligrams per square centimeter (mg/cm^2).
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Baseline and Week 48
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Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period
時間枠:Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
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Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
|
|
S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period
時間枠:Baseline, Weeks 12, 24, and 48
|
S-Sclerostin and P-Dkk1 are biological markers of bone and cartilage metabolism measured as picograms/milliliter (pg/mL).
Baseline is the closest value plus or minus (+/-) 1 month around the first tocilizumab infusion.
If values before and after the first infusion were eligible, the value before was taken into account.
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Baseline, Weeks 12, 24, and 48
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Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period
時間枠:Baseline and Weeks 12, 24, and 48
|
S-PIIINP, S-CTX-I, and S-PINP are biological markers of bone and cartilage metabolism.
Baseline is the closest value +/- 1 month around the first tocilizumab infusion.
If values before and after the first infusion were eligible, the value before was taken into account.
|
Baseline and Weeks 12, 24, and 48
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Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period
時間枠:Baseline and Weeks 12 and 48
|
S-OGP is a biological marker of bone and cartilage metabolism measured as picomoles per liter (pmol/L).
Baseline is the closest value +/- 1 month around the first tocilizumab infusion.
If values before and after the first infusion were eligible, the value before was taken into account.
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Baseline and Weeks 12 and 48
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Weekly Methotrexate (MTX) Dose
時間枠:Baseline and Weeks 24 and 48
|
Before entering the study, participants had to be treated with MTX for at least 12 weeks and at a stable dose for at least 8 weeks before the screening visit (10-25 mg per week [mg/week] of oral or parenteral MTX).
During the study, treatment with MTX had to be stable during the first month and then could be continued or modified, at the investigator's discretion.
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Baseline and Weeks 24 and 48
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HAQ-DI During the Double-Blind Treatment Period
時間枠:Screening and Week 4
|
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Screening and Week 4
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HAQ-DI During the Open Treatment Period
時間枠:Baseline and Weeks 12, 24, 36, and 48
|
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
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Baseline and Weeks 12, 24, 36, and 48
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Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period
時間枠:Day 0, Week 1, and Week 4
|
FACIT-F is a 13-item questionnaire.
Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much).
The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue.
For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response).
The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score).
A higher score reflects an improvement in the participant's health status.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Day 0, Week 1, and Week 4
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Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period
時間枠:Week 1 and Week 4
|
FACIT-F is a 13-item questionnaire.
Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much).
The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue.
For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response).
The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score).
A higher score reflects an improvement in the participant's health status.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Week 1 and Week 4
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FACIT-F During the Open Treatment Period
時間枠:Baseline, Weeks 12, 24, 36, and 48
|
FACIT-F is a 13-item questionnaire.
Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much).
The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue.
For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response).
The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score).
A higher score reflects an improvement in the participant's health status.
Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.
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Baseline, Weeks 12, 24, 36, and 48
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Hemoglobin Concentration During the Double-Blind Treatment Period
時間枠:Baseline and Weeks 1 and 4
|
Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as grams per deciliter (g/dL).
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Baseline and Weeks 1 and 4
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Hemoglobin Concentration During the Open Treatment Period
時間枠:Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
|
Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as g/dL.
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Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
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Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period
時間枠:Baseline and Weeks 1 and 4
|
Twenty-eight joints were assessed for tenderness.
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.
Baseline = value at Day 0 if available, value at screening otherwise.
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Baseline and Weeks 1 and 4
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Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period
時間枠:Weeks 1 and 4
|
Twenty-eight joints were assessed for tenderness.
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.
|
Weeks 1 and 4
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TJC Based on 28-Joint Count During the Open Treatment Period
時間枠:Baseline and Weeks 12, 24, 36, and 48
|
Twenty-eight joints were assessed for tenderness and joints were classified as tender (1)/not tender (0), giving a total possible tender joint count score of 0 to 28.
Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.
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Baseline and Weeks 12, 24, 36, and 48
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TJC Based on 40-Joint Count During the Double-Blind Treatment Period
時間枠:Baseline and Weeks 1 and 4
|
Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.
Baseline = value at Day 0 if available, value at screening otherwise.
|
Baseline and Weeks 1 and 4
|
Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period
時間枠:Weeks 1 and 4
|
Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.
|
Weeks 1 and 4
|
TJC Based on 40-Joint Count During the Open Treatment Period
時間枠:Baseline and Weeks 12, 24, 36, and 48
|
Forty joints were assessed for tenderness (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40.
Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.
|
Baseline and Weeks 12, 24, 36, and 48
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Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period
時間枠:Baseline and Weeks 1 and 4
|
Twenty-eight joints were assessed for swelling.
Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.
Baseline = value at Day 0 if available, value at screening otherwise.
|
Baseline and Weeks 1 and 4
|
Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period
時間枠:Weeks 1 and 4
|
Twenty-eight joints were assessed for swelling.
Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.
|
Weeks 1 and 4
|
Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period
時間枠:Baseline and Weeks 12, 24, 36, and 48
|
Twenty-eight joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints) .
Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.
Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.
|
Baseline and Weeks 12, 24, 36, and 48
|
SJC Based on 40-Joint Count During the Double-Blind Treatment Period
時間枠:Baseline and Weeks 1 and 4
|
Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40.
Baseline = value at Day 0 if available, value at screening otherwise.
|
Baseline and Weeks 1 and 4
|
Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period
時間枠:Weeks 1 and 4
|
Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40.
|
Weeks 1 and 4
|
SJC Based on 40-Joint Count During the Open Treatment Period
時間枠:Baseline and Weeks 12, 24, 36, and 48
|
Forty joints were assessed for swelling (5 MCP [left and right] joints, 5 PIP [left and right joints], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP [left and right] joints).
Joints were classified as swollen (1)/not swollen (0) for a total possible score of 0 to 40.
Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.
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Baseline and Weeks 12, 24, 36, and 48
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Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period
時間枠:Baseline and Weeks 1 and 4
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DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
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Baseline and Weeks 1 and 4
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DAS28 During the Open Treatment Period
時間枠:Baseline and Weeks 12, 24, 36, and 48
|
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
|
Baseline and Weeks 12, 24, 36, and 48
|
Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period
時間枠:Baseline and Weeks 1 and 4
|
DAS40 calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
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Baseline and Weeks 1 and 4
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DAS40 During the Open Treatment Period
時間枠:Baseline and Weeks 12, 24, 36, and 48
|
DAS40 was calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate, and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS40 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
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Baseline and Weeks 12, 24, 36, and 48
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協力者と研究者
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スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年6月1日
一次修了 (実際)
2011年10月1日
研究の完了 (実際)
2011年10月1日
試験登録日
最初に提出
2009年8月18日
QC基準を満たした最初の提出物
2009年9月14日
最初の投稿 (見積もり)
2009年9月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年9月22日
QC基準を満たした最後の更新が送信されました
2014年9月15日
最終確認日
2014年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
tocilizumab [RoActemra/Actemra]の臨床試験
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Hoffmann-La Roche完了
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Hoffmann-La Roche完了