A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00887341
First received: April 22, 2009
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Tocilizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Appearance of infusion reactions [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical remission(DAS28<2.6); ACR20/50/70/90 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Adverse events;laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]
| Enrollment: | 77 |
| Study Start Date: | May 2009 |
| Study Completion Date: | May 2011 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration
|
| Active Comparator: 2 |
Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887341
Locations
| Spain | |
| Alcala de Henares, Spain, 28805 | |
| Alzira, Spain, 46600 | |
| Avila, Spain, 05071 | |
| Badalona, Spain, 08915 | |
| Castellon, Spain, 12004 | |
| Galdakao, Spain, 48960 | |
| Gijon, Spain, 33394 | |
| Hospitalet de Llobregat, Spain, 08906 | |
| Madrid, Spain, 28935 | |
| Madrid, Spain, 28031 | |
| Menorca, Spain, 07701 | |
| Mollet Del Valles, Spain, 08100 | |
| Oviedo, Spain, 33006 | |
| Palma de Mallorca, Spain, 07198 | |
| Palma de Mallorca, Spain, 07014 | |
| San Juan, Spain, 03550 | |
| San Sebastian de Los Reyes, Spain, 28702 | |
| Torrelavega, Spain, 39300 | |
| Valencia, Spain, 46009 | |
| Vigo, Spain, 36214 | |
| Vigo, Spain, 36204 | |
| Villajoyosa, Spain, 03570 | |
| Vitoria, Spain, 01009 | |
| Zaragoza, Spain, 50009 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00887341 History of Changes |
| Other Study ID Numbers: | ML22254, 2008-006443-39 |
| Study First Received: | April 22, 2009 |
| Last Updated: | July 19, 2011 |
| Health Authority: | Spain: Ministry of Health |
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 May 23, 2013