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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

15. september 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

103

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Amiens, Frankrig, 80054
      • Amiens, Frankrig, 80094
      • Bayonne, Frankrig, 64109
      • Bois Guillaume, Frankrig, 76233
      • Bordeaux, Frankrig, 33076
      • Brest, Frankrig, 29609
      • Cahors, Frankrig, 46005
      • Chambray Les Tours, Frankrig, 37171
      • Clermont-ferrand, Frankrig, 63003
      • Echirolles, Frankrig, 38434
      • La Roche Sur Yon, Frankrig, 85925
      • Limoges, Frankrig, 87042
      • Lyon, Frankrig, 69437
      • Metz, Frankrig, 57077
      • Nantes, Frankrig, 44035
      • Orleans, Frankrig, 45000
      • Paris, Frankrig, 75651
      • Paris, Frankrig, 75679
      • Paris, Frankrig, 75877
      • Rennes, Frankrig, 35203
      • St Priest En Jarez, Frankrig, 42277
      • Toulouse, Frankrig, 31059

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Medicin: tocilizumab [RoActemra/Actemra]
single iv infusion 8 mg/kg
Medicin: tocilizumab [RoActemra/Actemra]
iv infusion 8mg/kg every 4 weeks for 11 months
Placebo komparator: 2
Medicin: placebo
enkelt iv infusion
Eksperimentel: 3
Medicin: tocilizumab [RoActemra/Actemra]
single iv infusion 8 mg/kg
Medicin: tocilizumab [RoActemra/Actemra]
iv infusion 8mg/kg every 4 weeks for 11 months

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4
Tidsramme: 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.
Week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period
Tidsramme: 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.
Baseline, Weeks 1 and 4
Patient Global Assessment of Disease Activity During the Open Treatment Period
Tidsramme: 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
Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period
Tidsramme: 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
Tidsramme: 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
Patient Global Assessment of Pain During the Double-Blind Treatment Period
Tidsramme: 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
Patient Global Assessment of Pain During the Open Treatment Period
Tidsramme: 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
Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound
Tidsramme: 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.
Baseline, Weeks 1 and 4
Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound
Tidsramme: 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.
Baseline, Weeks 1 and 4
Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound
Tidsramme: 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.
Weeks 12, 24, and 48
Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound
Tidsramme: 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.
Weeks 12, 24, and 48
Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period
Tidsramme: Baseline, Weeks 1 and 4
Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm per hour (mm/hr). A reduction in ESR indicates improvement.
Baseline, Weeks 1 and 4
Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment
Tidsramme: Weeks 1 and 4
Erythrocyte sedimentation rate is a biological marker of inflammation. A negative change indicates improvement.
Weeks 1 and 4
Erythrocyte Sedimentation Rate During the Open Treatment Period
Tidsramme: Baseline, Weeks 12, 24, 36, and 48
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.
Baseline, Weeks 12, 24, 36, and 48
C-Reactive Protein During the Double-Blind Treatment Period
Tidsramme: Baseline, Weeks 1 and 4
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.
Baseline, Weeks 1 and 4
Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period
Tidsramme: Weeks 1 and 4
C-Reactive protein (CRP) is a biological marker of inflammation. Negative changes from baseline indicate improvement.
Weeks 1 and 4
C- Reactive Protein During the Open Treatment Period
Tidsramme: 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.
Baseline, Weeks 12, 24, 36, and 48
Serum Amyloid A Component During the Double-Blind Treatment Period
Tidsramme: Baseline, Weeks 1 and 4
Serum Amyloid A (SAA) component is a biological marker of inflammation and is measured in mg/L. A reduction in SAA indicates improvement.
Baseline, Weeks 1 and 4
Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period
Tidsramme: 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
Serum Amyloid A Component During the Open Treatment Period
Tidsramme: Baseline, Weeks 12, 24, 36, and 48
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.
Baseline, Weeks 12, 24, 36, and 48
Beta 2 Microglobulin Levels During the Open Treatment Period
Tidsramme: 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
Beta 2 Microglobulin Levels During the Double-Blind Treatment Period
Tidsramme: 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
Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period
Tidsramme: 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
Bone Mineral Density
Tidsramme: 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).
Baseline and Week 48
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period
Tidsramme: Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
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
Tidsramme: 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.
Baseline, Weeks 12, 24, and 48
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
Tidsramme: 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
Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period
Tidsramme: 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.
Baseline and Weeks 12 and 48
Weekly Methotrexate (MTX) Dose
Tidsramme: 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.
Baseline and Weeks 24 and 48
HAQ-DI During the Double-Blind Treatment Period
Tidsramme: 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.
Screening and Week 4
HAQ-DI During the Open Treatment Period
Tidsramme: 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.
Baseline and Weeks 12, 24, 36, and 48
Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period
Tidsramme: 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.
Day 0, Week 1, and Week 4
Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period
Tidsramme: 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.
Week 1 and Week 4
FACIT-F During the Open Treatment Period
Tidsramme: 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.
Baseline, Weeks 12, 24, 36, and 48
Hemoglobin Concentration During the Double-Blind Treatment Period
Tidsramme: 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).
Baseline and Weeks 1 and 4
Hemoglobin Concentration During the Open Treatment Period
Tidsramme: 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.
Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period
Tidsramme: 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.
Baseline and Weeks 1 and 4
Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period
Tidsramme: 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
TJC Based on 28-Joint Count During the Open Treatment Period
Tidsramme: 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.
Baseline and Weeks 12, 24, 36, and 48
TJC Based on 40-Joint Count During the Double-Blind Treatment Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Baseline and Weeks 12, 24, 36, and 48
Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period
Tidsramme: Baseline and Weeks 1 and 4
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 1 and 4
DAS28 During the Open Treatment Period
Tidsramme: 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
Tidsramme: 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.
Baseline and Weeks 1 and 4
DAS40 During the Open Treatment Period
Tidsramme: 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.
Baseline and Weeks 12, 24, 36, and 48

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2009

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

18. august 2009

Først indsendt, der opfyldte QC-kriterier

14. september 2009

Først opslået (Skøn)

15. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML22017
  • 2008-008309-23

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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