Clinical trial NCT00887341: A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion
timeFrame: Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24
Secondary outcomes:
measure: Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: Percentage of Participants Discontinuing Tocilizumab for Any Reason
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: 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
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: Percentage of Participants Achieving a DAS28 Score <3.2 by Visit
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: DAS28 Score by Visit
timeFrame: Weeks 4, 8, 12, 16, 20, and Final Visit
measure: Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
measure: C-Reactive Protein (CRP) Levels
timeFrame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit
measure: Erythrocyte Sedimentation Rate
timeFrame: Baseline, Weeks 2, 4, 8, 12,16, 20, and 24
measure: HAQ-DI Score by Visit
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI
timeFrame: Weeks 4, 8, 12, 16, 20 and Final Visit
Other outcomes:
Locations:
city: Vitoria
country: Spain
state: Alava
city: Villajoyosa
country: Spain
state: Alicante
city: Gijon
country: Spain
state: Asturias
city: Oviedo
country: Spain
state: Asturias
city: Badalona
country: Spain
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Mollet del Valles
country: Spain
state: Barcelona
city: Torrelavega
country: Spain
state: Cantabria
city: Menorca
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Alcala de Henares
country: Spain
state: Madrid
city: San Sebastian de los Reyes
country: Spain
state: Madrid
city: Vigo
country: Spain
state: Pontevedra
city: Vigo
country: Spain
state: Pontevedra
city: Alzira
country: Spain
state: Valencia
city: San Juan
country: Spain
state: Valencia
city: Valenica
country: Spain
state: Valencia
city: Galdakao
country: Spain
state: Vizcaya
city: Avila
country: Spain
city: Castellon
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: