A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.

This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: tocilizumab [RoActemra/Actemra]

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• Slovakia
  • Piestany, Slovakia, 921 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients >/= 18 years of age
• moderate to severe active rheumatoid arthritis
• inadequate response, or intolerance to previous therapy with one or more traditional DMARDs
• DAS >3.6
• pneumology examination (including chest x-ray and quantiferon)

Exclusion Criteria:

• < 18 years of age
• active infection
• active tuberculosis
• uncontrolled hyperlipoproteinaemia
• demyelinating disorders
• concomitant anti-TNF drugs
• history of intestinal ulceration and diverticulitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Drug: tocilizumab [RoActemra/Actemra]; tocilizumab 8 mg/kg intravenous infusion once in 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Adherent to Original Treatment	Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.	Week 24
Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason		Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason		Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants Withdrawing From the Study Prematurely for Any Reason		Weeks 0, 4, 8, 12, 16, 20, and 24
Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg		Weeks 0, 4, 8, 12, 16, and 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score Based on 28-Joint Count (DAS28)	DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.	Weeks 0, 4, 12, and 24
Patient Global Assessment of Pain	Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.	Weeks 0, 4, 8, 12, 16, 20, and 24
Patient Global Assessment of Disease Activity	The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.	Weeks 0, 4, 8, 12, 16, 20, and 24
Physician's Global Assessment of Disease Activity	Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.	Weeks 0, 4, 8, 12, 16, 20, and 24
Swollen Joint Count (SJC)	The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.	Weeks 0, 4, 8, 12, 16, 20, and 24
Tender Joint Count (TJC)	The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.	Weeks 0, 4, 8, 12, 16, 20, and 24
Erythrocyte Sedimentation Rate (ESR)	ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.	Weeks 0, 4, 12, 20, and 24
C-Reactive Protein (CRP)	CRP is an acute phase protein. Levels of CRP increase with inflammation.	Weeks 0, 4, 12, 20, and 24
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score	The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.	Weeks 0, 4, 8, 12, 16, 20, and 24
Short Form-36 (SF-36)	The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.	Weeks 0, 12, and 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 9, 2009
• First Submitted That Met QC Criteria: November 9, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Estimate): August 13, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML22508; 2009-011520-53