Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01562327
First received: March 21, 2012
Last updated: October 18, 2016
Last verified: October 2016
  Purpose
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis. Data will be collected from each eligible participant initiated on RoActemra/Actemra treatment by their treating physician according to local label for 6 months from start of treatment.

Condition Intervention
Rheumatoid Arthritis
Drug: Tocilizumab

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 Actemra

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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

Secondary Outcome Measures:
  • Percentage of Participants With Systemic Manifestations of RA at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least one of the conditions.

  • Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Previously Received DMARDs [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Reason for DMARDs Withdrawal at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Previously Received Biologic Agents [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Reason for Biologic Agent Withdrawal at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Reasons for Dose Modifications [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    Percentage of participants on Tocilizumab as monotherapy or combination therapy (with DMARDs) were reported at start of treatment and at 6 months from the start of treatment.

  • Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A decrease in score indicated improvement.

  • Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A decrease in score indicates improvement.

  • Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
    DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.

  • Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
    CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.

  • Simplified Disease Activity (SDAI) Response Classification [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
    The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.

  • European League Against Rheumatism (EULAR) Response [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
    Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6.

  • Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 [ Time Frame: Month 3, Month 6 ] [ Designated as safety issue: No ]
    ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.

  • Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.

  • Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.

  • Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.

  • Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    The Patient Global Assessment of fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.

  • Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.

  • Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, Month 6 ] [ Designated as safety issue: No ]
    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 as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.

  • Percentage of Participants With an Adverse Event (AE) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.


Enrollment: 50
Study Start Date: February 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tocilizumab
Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
Drug: Tocilizumab
Participants received tocilizumab according to individualized physician-prescribed regimens.
Other Name: Actemra

  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
Rheumatoid arthritis participants treated with tocilizumab
Criteria

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis
  • Participants initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including participants who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

  • RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
  • Previous RoActemra/Actemra treatment 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: NCT01562327

Locations
Argentina
Buenos Aires, Argentina, C1426AAL
Buenos Aires, Argentina, C1428DQG
Ciudad Autonoma de, Argentina, C1221ADC
Florencio Varela, Argentina, 1888
La Plata, Argentina, 1900
San Juan, Argentina, 5400
San Miguel De Tucuman, Argentina, T4000IFP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01562327     History of Changes
Other Study ID Numbers: ML28142 
Study First Received: March 21, 2012
Results First Received: June 29, 2016
Last Updated: October 18, 2016
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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 December 02, 2016