Clinical trial NCT00951275: A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official title: A Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-08-04
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* rheumatoid arthritis \>=6 months duration;
* DAS28\>=3.2;
* inadequate response to prior treatment with a stable dose (\>=8 weeks) of DMARD therapy.

Exclusion Criteria:

* rheumatic autoimmune disease other than rheumatoid arthritis;
* history of or current inflammatory joint disease other than rheumatoid arthritis;
* unsuccessful treatment with an anti-TNF agent;
* previous/concurrent treatment with any cell-depleting therapies.

Primary outcomes:
measure: Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin
timeFrame: Week 4
measure: Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores
timeFrame: Week 4
Secondary outcomes:
measure: Mean Hemoglobin Levels During the Study
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
measure: Improvement of Anemia Assessed as Change From Baseline in Hemoglobin
timeFrame: Weeks 2, 4, 8, 12, 16, 20, and 24
measure: FACIT-F Scores
timeFrame: Baseline, Weeks 2, 4, 8,12, 16, 20 and 24
measure: Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores
timeFrame: Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in TJC
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in SJC
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in HAQ-DI
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP)
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in ESR
timeFrame: Week 24
measure: Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category
timeFrame: Week 24
measure: Percentage of Participants With a Response at Week 24 by DAS28 Category
timeFrame: Week 24
measure: Percent Change From Baseline to Week 24 in DAS28 Score
timeFrame: Week 24
measure: Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin
timeFrame: Week 24
measure: Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ)
timeFrame: Baseline
measure: Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ
timeFrame: Weeks 12 and 24
measure: Number of Hours as Assessed by SF-HLQ
timeFrame: Baseline
measure: Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ
timeFrame: Baseline
measure: SF-HLQ Hindrance Score
timeFrame: Baseline
measure: Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score
timeFrame: Baseline
measure: Efficiency as Assessed by SF-HLQ
timeFrame: Baseline
measure: Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ
timeFrame: Baseline
Other outcomes:
Locations:
city: Benevento
country: Italy
facility: Azienda Ospedaliera Rummo; Divisione Di Reumatologia
state: Campania
city: Napoli
country: Italy
facility: Azienda Ospedaliera A. Cardarelli; Medicina III - Divisione di Reumatologia
state: Campania
city: Napoli
country: Italy
facility: UNIVERSITÀ DI NAPOLI FEDERICO II; Dipartimento di Immunologia Clinica ed Allergologia
state: Campania
city: Scafati
country: Italy
facility: Ospedale M. Scarlato - Asl Sa1; U.O. Di Reumatologia
state: Campania
city: Telese Terme
country: Italy
facility: Irccs Fondazione Salvatore Maugeri-Istituto Scientifico Di Telese;U.O. Riabilitazione Reumatologica
state: Campania
city: Bologna
country: Italy
facility: A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2
state: Emilia-Romagna
city: Parma
country: Italy
facility: Az. Ospedaliera Univ. di Parma; Medicina Interna e Reumatologia
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: Ospedale Guglielmo Da Saliceto Unità Operativa Semplice di Reumatologia e Immunologia
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Tor Vergata; Divisione Di Reumatologia
state: Lazio
city: Roma
country: Italy
facility: Ospedale Nuovo Regina Margherita; Divisione di Medicina Interna Reumatologia
state: Lazio
city: Roma
country: Italy
facility: Ospedale S.Pietro Fatebenefratelli; Divisione di Reumatologia
state: Lazio
city: Viterbo
country: Italy
facility: Ospedale Belcolle; Divisione Di Reumatologia
state: Lazio
city: Savona
country: Italy
facility: Ospedale San Paolo; Divisione di Reumatologia
state: Liguria
city: Bergamo
country: Italy
facility: ASST PAPA GIOVANNI XXIII; Reumatologia Day Hospital-Torre 2 terzo piano
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Reumatologia (Medicina I)
state: Lombardia
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas; Immunologia Clinica E Reumatologia
state: Lombardia
city: Torino
country: Italy
facility: Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica
state: Piemonte
city: Brindisi
country: Italy
facility: Ospedale Perrino; Medicina Interna - Divisione di Reumatologia
state: Puglia
city: Martina Franca
country: Italy
facility: Presidio Ospedaliero Valle D'itria; Divisione Di Nefrologia
state: Puglia
city: San Cesario Di Lecce
country: Italy
facility: Ospedale Galateo; U.O. Di Reumatologia
state: Puglia
city: Catania
country: Italy
facility: Ospedale Vittorio Emanuele Ii; U.O. Reumatologia Clinica Medica Condorelli
state: Sicilia
city: Gazzi
country: Italy
facility: A.U.O. G. Martino- Policlinico Univ. Gazzi; Dept. Di Medicina Interna, Divisione Di Reumatologia
state: Sicilia
city: Palermo
country: Italy
facility: Arnas Ospedale Civico; Medicina Interna II
state: Sicilia
city: Palermo
country: Italy
facility: Az. Osp. Villa Sofia; Unità Operativa Reumatologia
state: Sicilia
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia- Cervello X; Divisione Medicina I
state: Sicilia
city: Massa
country: Italy
facility: Ospedale Di Massa; Divisione Di Reumatologia
state: Toscana
city: Venezia
country: Italy
facility: Ospedale SS Giovanni e Paolo; Divisione Di Reumatologia
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: