A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00887341
First received: April 22, 2009
Last updated: October 20, 2014
Last verified: October 2014

April 22, 2009
October 20, 2014
May 2009
December 2010   (final data collection date for primary outcome measure)
Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion [ Time Frame: Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24 ] [ Designated as safety issue: Yes ]
An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion.
Appearance of infusion reactions [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00887341 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE) [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
  • Percentage of Participants Discontinuing Tocilizumab for Any Reason [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
  • Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
    DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference.
  • Percentage of Participants Achieving a DAS28 Score <3.2 by Visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
    DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.
  • Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
    DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission.
  • DAS28 Score by Visit [ Time Frame: Weeks 4, 8, 12, 16, 20, and Final Visit ] [ Designated as safety issue: No ]
    DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 >3.2 to 5.1=moderate to high disease activity; DAS28 <2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value.
  • Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
    ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein [CRP])
  • Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
    ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
  • Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
    ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
  • Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
    ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
  • C-Reactive Protein (CRP) Levels [ Time Frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit ] [ Designated as safety issue: No ]
    CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L).
  • Erythrocyte Sedimentation Rate [ Time Frame: Baseline, Weeks 2, 4, 8, 12,16, 20, and 24 ] [ Designated as safety issue: No ]
    ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement.
  • HAQ-DI Score by Visit [ Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
    HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
  • Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI [ Time Frame: Weeks 4, 8, 12, 16, 20 and Final Visit ] [ Designated as safety issue: No ]
    HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.
  • Clinical remission(DAS28<2.6); ACR20/50/70/90 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events;laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Phase II Multi-centre, Randomized, Parallel Group, Pilot Trial to Compare the Incidence of Tocilizumab Related Infusion Reactions in Moderate to Severe RA Patients When Infusion is Made Over 1 Hour Against 31 Minutes

This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: tocilizumab [RoActemra/Actemra]
    8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration
  • Drug: tocilizumab [RoActemra/Actemra]
    8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration
  • Experimental: 1
    Intervention: Drug: tocilizumab [RoActemra/Actemra]
  • Active Comparator: 2
    Intervention: Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • active moderate or severe rheumatoid arthritis;
  • active disease for >6 months;
  • inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.

Exclusion Criteria:

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • prior history of, or current inflammatory joint disease other than rheumatoid arthritis;
  • major surgery (including joint surgery) within 8 weeks prior to screening, or planned major surgery within 6 months following enrollment.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00887341
ML22254, 2008-006443-39
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP