Clinical trial NCT01010503: A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Adherent to Original Treatment
timeFrame: Week 24
measure: Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Withdrawing From the Study Prematurely for Any Reason
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg
timeFrame: Weeks 0, 4, 8, 12, 16, and 20
Secondary outcomes:
measure: Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: Weeks 0, 4, 12, and 24
measure: Patient Global Assessment of Pain
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Patient Global Assessment of Disease Activity
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Physician's Global Assessment of Disease Activity
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Swollen Joint Count (SJC)
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Tender Joint Count (TJC)
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Weeks 0, 4, 12, 20, and 24
measure: C-Reactive Protein (CRP)
timeFrame: Weeks 0, 4, 12, 20, and 24
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
timeFrame: Weeks 0, 4, 8, 12, 16, 20, and 24
measure: Short Form-36 (SF-36)
timeFrame: Weeks 0, 12, and 24
Other outcomes:
Locations:
city: Piestany
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: