A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01663506
First received: August 8, 2012
Last updated: November 3, 2015
Last verified: November 2015
  Purpose
This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed for 12 months.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity [ Time Frame: Up to Month 12 ] [ Designated as safety issue: No ]
    Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (>=) 75 days between two consecutive doses of study drug.

  • Number of Participants With Comorbidities at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.

  • Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of Participants With Prior Exposure of Biologics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: Baseline, Month 3, 6, and 12 ] [ Designated as safety issue: No ]
    DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (<=) 2.6 meant clinical remission; DAS28 <=3.2 meant low disease activity; DAS28 greater than (>) 3.2 to 5.1 implied moderate disease activity; and DAS28 >5.1 implied high disease activity.

  • Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 [ Time Frame: Month 3, 6, and 12 ] [ Designated as safety issue: No ]
    The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline >1.2 with DAS28 <= 3.2; moderate responders: decrease from baseline >1.2 with DAS28 >3.2 or decrease from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: decrease from baseline <= 0.6 or decrease from baseline >0.6 and <=1.2 with DAS28 >5.1.

  • Physician Global Assessment (PGA) of Disease Activity [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.

  • Patient Global Assessment (PtGA) of Disease Activity Score [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    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 was scored on a 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 divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.

  • Visual Analog Scale (VAS)-Pain [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.

  • Visual Analog Fatigue Scale (VAFS) [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.

  • Visual Analog Scale-Morning Stiffness (VAS-MS) [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.

  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    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 higher rate is consistent with inflammation.

  • C-Reactive Protein (CRP) [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

  • Number of Swollen and Tender Joints Based on 66 and 68 Joints [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) 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 each visit, 0 = no tenderness, 1 = tenderness.

  • Number of Swollen and Tender Joints Based on 28 Joints [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) 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 each visit, 0 = no tenderness, 1 = tenderness.

  • Simplified Disease Activity Index (SDAI) Score [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.

  • Clinical Disease Activity Index (CDAI) Score [ Time Frame: Baseline, Month 6, and 12 ] [ Designated as safety issue: No ]
    The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.

  • Number of Participants Who Received Tocilizumab as Monotherapy [ Time Frame: Baseline, Study end (at Month 12 or at time of study discontinuation) ] [ Designated as safety issue: No ]
  • Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs) [ Time Frame: Baseline, Study end (at Month 12 or at time of study discontinuation) ] [ Designated as safety issue: No ]
  • Number of Participants Receiving Oral Corticosteroids [ Time Frame: Baseline, Month 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Number of Participants With Disease Activity Status Based on DAS28 Score [ Time Frame: Baseline, Month 3, 6, and 12 ] [ Designated as safety issue: No ]
    Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score <= 2.6; low disease activity: DAS28 <=3.2; moderate disease activity: DAS28 <=5.1; and high disease activity: DAS28 >5.1.

  • Number of Participants With Disease Activity Status Based on SDAI Score [ Time Frame: Baseline, Month 3, 6, and 12 ] [ Designated as safety issue: No ]
    Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score <= 3.3; low disease activity: SDAI <=11.0; moderate disease activity: SDAI <=26.0; and high disease activity: SDAI >26.0.

  • Number of Participants With Disease Activity Status Based on CDAI Score [ Time Frame: Baseline, Month 3, 6, and 12 ] [ Designated as safety issue: No ]
    Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score <= 2.8; low disease activity: CDAI <=10.0; moderate disease activity: CDAI <=22.0; and high disease activity: CDAI >22.0.


Enrollment: 23
Study Start Date: April 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra (tocilizumab)
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 week prior to the enrolment visit

Exclusion Criteria:

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663506

Locations
Estonia
Tallinn, Estonia, 11312
Tallinn, Estonia, 13419
Tartu, Estonia, 51014
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01663506     History of Changes
Other Study ID Numbers: ML28311 
Study First Received: August 8, 2012
Results First Received: November 3, 2015
Last Updated: November 3, 2015
Health Authority: Estonia: The State Agency for Medicine

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 25, 2016