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A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting

14. April 2017 aktualisiert von: Hoffmann-La Roche

CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab

This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of tocilizumab therapy in a routine clinical practice in participants with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a maximum study duration of 18 months.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

151

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Italien
    • Abruzzo
      • Coppito, Abruzzo, Italien, 67100
    • Calabria
      • Reggio Calabria, Calabria, Italien, 89133
    • Campania
      • Benevento, Campania, Italien, 82100
      • Telese Terme, Campania, Italien, 82037
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138
    • Lazio
      • Roma, Lazio, Italien, 00128
    • Lombardia
      • Bergamo, Lombardia, Italien, 24127
      • Castel Goffredo, Lombardia, Italien, 46042
      • Gavardo, Lombardia, Italien, 25085
      • Milano, Lombardia, Italien, 20122
      • Monza, Lombardia, Italien, 20052
      • Pavia, Lombardia, Italien, 27100
    • Piemonte
      • Novara, Piemonte, Italien, 28100
    • Puglia
      • Barletta, Puglia, Italien, 76121
      • Casarano (LE), Puglia, Italien, 73042
      • Foggia, Puglia, Italien, 71100
    • Sicilia
      • Catania, Sicilia, Italien, 95126
      • Catania, Sicilia, Italien, 95124
      • Palermo, Sicilia, Italien, 90146
    • Toscana
      • Firenze, Toscana, Italien, 50139
      • Pisa, Toscana, Italien, 56100
    • Veneto
      • Cona (Ferrara), Veneto, Italien, 44124
      • Verona, Veneto, Italien, 37126
      • Verona, Veneto, Italien, 37134

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Participants with moderate to severe RA who are being treated or begin treatment with tocilizumab according to routine clinical practice.

Beschreibung

Inclusion Criteria:

  • Diagnosis of moderate to severe RA according to revised American College of Rheumatology criteria
  • Participants have started tocilizumab treatment according to routine clinical practice within 3 months prior to site opening and still in treatment, as well as participants who began treatment at enrollment

Exclusion Criteria:

  • Participants who have started tocilizumab treatment more than 3 months prior to site opening
  • Participants who have previously received tocilizumab in a clinical trial setting or for compassionate use
  • Participants who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
  • Participants with a history of autoimmune disease or joint inflammatory disease other than RA

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
RA Participants
Participants with moderate or severe RA who are under tocilizumab treatment in routine clinical practice (in accordance with the local label) will be observed for 6 months from the start of treatment.
Arzneimittel: Tocilizumab
Tocilizumab will be administered in routine clinical practice in accordance with local label. Study protocol does not specify/enforce any treatment regimen.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants on TCZ Treatment at Month 6
Zeitfenster: Month 6
Percentage of participants on TCZ treatment at Month 6 was calculated as: [(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.
Month 6

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
C-Reactive Protein (CRP) at Baseline
Zeitfenster: Baseline
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline
Percentage of Participants by TCZ Dose at Month 6
Zeitfenster: Month 6
TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the [(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)] multiplied by 100.
Month 6
Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Zeitfenster: Baseline
Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in "IR to biologic group". Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the "DMARDs intolerance and/or IR" group.
Baseline
Time Elapsed From Diagnosis of RA
Zeitfenster: Baseline (assessed retrospectively)
Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.
Baseline (assessed retrospectively)
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
Zeitfenster: Baseline
Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.
Baseline
Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline
Zeitfenster: Baseline
The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.
Baseline
Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline
Zeitfenster: Baseline
The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.
Baseline
Participant Assessment of Morning Stiffness Using VAS at Baseline
Zeitfenster: Baseline
The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.
Baseline
Participant Assessment of Fatigue Using VAS at Baseline
Zeitfenster: Baseline
Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.
Baseline
Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline
Zeitfenster: Baseline
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.
Baseline
Tender Joint Count (TJC) at Baseline
Zeitfenster: Baseline
TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.
Baseline
Swollen Joint Count (SJC) at Baseline
Zeitfenster: Baseline
SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.
Baseline
Erythrocyte Sedimentation Rate (ESR) at Baseline
Zeitfenster: Baseline
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.
Baseline
Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline
Zeitfenster: Baseline
Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.
Baseline
Percentage of Participants With Evidence of Structural Joint Damage at Baseline
Zeitfenster: Baseline
Baseline
Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline
Zeitfenster: Baseline
Baseline
Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline
Zeitfenster: Baseline
RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.
Baseline
Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline
Zeitfenster: Baseline
Baseline
Percentage of Participants by Duration of Morning Stiffness at Baseline
Zeitfenster: Baseline
Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (<) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (>) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.
Baseline
Number of Participants With TCZ Dose Change According to the Reason for Change
Zeitfenster: Baseline up to Month 6
Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.
Baseline up to Month 6
Percentage of Participants by Number of TCZ Dose Modifications Per Participant
Zeitfenster: Baseline up to Month 6
The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.
Baseline up to Month 6
Time in Days Elapsed Between TCZ Infusions
Zeitfenster: Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8
The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.
Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8
Percentage of Participants With TCZ Infusion Interruption
Zeitfenster: Baseline up to Month 6
The percentage of participants with at least one infusion interruption was reported as "Yes". Participants with unknown infusion interruption were set to "No".
Baseline up to Month 6
Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation
Zeitfenster: Baseline up to Month 6
Baseline up to Month 6
Percentage of Participants With TCZ Reintroduction
Zeitfenster: Baseline up to Month 6
The percentage of participants with at least one TCZ reintroduction was reported as "Yes". Participants with unknown TCZ reintroduction were set to "No".
Baseline up to Month 6
Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline
Zeitfenster: Baseline
Baseline
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6
Zeitfenster: Baseline, Month 3, and Month 6
DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of < 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of > 3.2 and ≤ 5.1 represents moderate disease activity and a score of > 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Baseline, Month 3, and Month 6
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6
Zeitfenster: Baseline, Month 3, and Month 6
SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Baseline, Month 3, and Month 6
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6
Zeitfenster: Baseline, Month 3, and Month 6
The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Baseline, Month 3, and Month 6
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Zeitfenster: Baseline, Month 3, and Month 6
DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of < 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of >3.2 and ≤ 5.1 represents moderate disease activity, and a score of > 5.1 represents high (or severe) disease activity.
Baseline, Month 3, and Month 6
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Zeitfenster: Baseline, Month 3, and Month 6
SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity.
Baseline, Month 3, and Month 6
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Zeitfenster: Baseline, Month 3, and Month 6
CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity.
Baseline, Month 3, and Month 6
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Zeitfenster: Month 3 and Month 6
ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.
Month 3 and Month 6
Change From Baseline to Month 6 in TJC
Zeitfenster: Baseline and Month 6
TJC was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline and at Month 6. No tenderness = 0 and tenderness = 1.
Baseline and Month 6
Change From Baseline to Month 6 in SJC
Zeitfenster: Baseline and Month 6
SJC was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline and at Month 6. No swelling = 0 and swelling = 1.
Baseline and Month 6
Change From Baseline to Month 6 in PGH
Zeitfenster: Baseline and Month 6
The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.
Baseline and Month 6
Change From Baseline to Month 6 in PhGH
Zeitfenster: Baseline and Month 6
The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.
Baseline and Month 6
Change From Baseline to Month 6 in Patient's Assessment of Pain
Zeitfenster: Baseline and Month 6
Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.
Baseline and Month 6
Change From Baseline to Month 6 in HAQ-DI Score
Zeitfenster: Baseline and Month 6
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.
Baseline and Month 6
Change From Baseline to Month 6 in Participant Assessment of Fatigue
Zeitfenster: Baseline and Month 6
Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.
Baseline and Month 6
Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness
Zeitfenster: Baseline and Month 6
The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.
Baseline and Month 6
Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI
Zeitfenster: Month 3 and Month 6
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.
Month 3 and Month 6
Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Zeitfenster: Month 3 and Month 6
Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of >1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL >1.2 with DAS28 score > 3.2 to ≤ 5.1 or a chg from BL > 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL < 0.6 regardless initial DAS28 score or > 0.6 to ≤ 1.2 with DAS28 score of > 5.1.
Month 3 and Month 6
Time to DMARD Dose Reduction
Zeitfenster: Baseline up to Month 6
DMARDs that met the criteria for "concomitant medications" were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered.
Baseline up to Month 6
Time to DMARD Dose Withdrawal
Zeitfenster: Baseline up to Month 6
DMARDs that met the criteria for "concomitant medications" were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.
Baseline up to Month 6
Percentage of Participants by Reason for DMARD Withdrawal During the Study
Zeitfenster: Baseline up to Month 6
DMARDs that met the criteria for "concomitant medications" were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected.
Baseline up to Month 6
Time to Steroid Dose Reduction
Zeitfenster: Baseline up to Month 6
Steroids that met the criteria for "concomitant medications" were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered.
Baseline up to Month 6
Time to Steroid Dose Withdrawal
Zeitfenster: Baseline up to Month 6
Steroids that met the criteria for "concomitant medications" were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.
Baseline up to Month 6
Change From Baseline in CRP at Month 3 and Month 6
Zeitfenster: Baseline, Month 3, and Month 6
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Baseline, Month 3, and Month 6
Change From Baseline in ESR at Month 3 and Month 6
Zeitfenster: Baseline, Month 3, and Month 6
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Baseline, Month 3, and Month 6
CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
Zeitfenster: Baseline
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.
Baseline
Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
Zeitfenster: Baseline
DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.
Baseline
Percentage of Participants With and Without Morning Stiffness
Zeitfenster: Month 3 and Month 6

Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:

  1. Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present);
  2. Duration of morning stiffness, measured by ticking 1 of the six categories: < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day;
  3. Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness.

'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.
Month 3 and Month 6
Percentage of Participants by Duration of Morning Stiffness
Zeitfenster: Month 3 and Month 6
Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.
Month 3 and Month 6
CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6
Zeitfenster: Baseline
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.
Baseline
BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6
Zeitfenster: Baseline
Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.
Baseline
Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
Zeitfenster: Baseline and Month 6
The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Baseline and Month 6
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6
Zeitfenster: Baseline and Month 6
CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Baseline and Month 6
Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6
Zeitfenster: Baseline and Month 6
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Baseline and Month 6
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6
Zeitfenster: Baseline and Month 6
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Baseline and Month 6
Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
Zeitfenster: Baseline and Month 6
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Baseline and Month 6
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6
Zeitfenster: Baseline and Month 6
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Baseline and Month 6
Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6
Zeitfenster: Baseline and Month 6
Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Baseline and Month 6

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Sponsor

Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2012

Primärer Abschluss (Tatsächlich)

1. Dezember 2013

Studienabschluss (Tatsächlich)

1. Dezember 2013

Studienanmeldedaten

Zuerst eingereicht

7. August 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. August 2012

Zuerst gepostet (Schätzen)

14. August 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. April 2017

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ML28336

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