TL011 in Severe, Active Rheumatoid Arthritis Patients
This study has been completed.
Sponsor:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01123070
First received: May 11, 2010
Last updated: May 14, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis Biological: MabThera infusions |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Rituximab
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Compare pharmacokinetics (PK) of rituximab following IV infusions of TL011 and MabThera® in subjects with RA. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability of TL011 and MabThera® in subjects with RA [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
- Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and preliminary efficacy of TL011 and MabThera® in subjects with RA [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | February 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TL011
TL011 infusions
|
Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis
TL011 administered by 2 infusions, 2 weeks apart
|
|
Active Comparator: MabThera
MabThera infusions
|
Biological: MabThera infusions
MabThera, administered by 2 infusions, 2 weeks apart
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult subjects
- Rheumatoid arthritis as defined by the 1987 ACR Classification
- Severe active seropositive disease
- Inadequate response or intolerance to other DMARDs
- Treatment with MTX
Exclusion Criteria:
- Rheumatic autoimmune disease other than RA
- Active infection
- Known immunodeficiency syndrome
- Positive Hepatitis B surface antigen or antibodies to Hepatitis C
- History of cancer
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123070
Locations
| Czech Republic | |
| Teva Investigational Site 5428 | |
| Plzen, Czech Republic | |
| Teva Investigational Site 5426 | |
| Prague 2, Czech Republic | |
| Teva Investigational Site 5429 | |
| Uherske Hradiste, Czech Republic | |
| Hungary | |
| Teva Investigational Site 5122 | |
| Budapest, Hungary | |
| Teva Investigational Site 5123 | |
| Budapest, Hungary | |
| Teva Investigational Site 5125 | |
| Debrecen, Hungary | |
| Teva Investigational Site 5124 | |
| Szeged, Hungary | |
| Italy | |
| Teva Investigational Site 3077 | |
| Firenze, Italy | |
| Teva Investigational Site 3075 | |
| Genova, Italy | |
| Teva Investigational Site 3076 | |
| Siena, Italy | |
| Spain | |
| Teva Investigational Site 3170 | |
| Barakaldo, Spain | |
| Teva Investigational Site 3168 | |
| Guadalajara, Spain | |
| Teva Investigational Site 3167 | |
| Madrid, Spain | |
| Teva Investigational Site 3169 | |
| Sevilla, Spain | |
| United Kingdom | |
| Teva Investigational Site 3434 | |
| Manchester, United Kingdom | |
| Teva Investigational Site 3433 | |
| Staffordshire, United Kingdom | |
| Teva Investigational Site 3435 | |
| Wirral, Merseyside, United Kingdom | |
Sponsors and Collaborators
Teva Pharmaceutical Industries
More Information
No publications provided
| Responsible Party: | Teva Pharmaceutical Industries |
| ClinicalTrials.gov Identifier: | NCT01123070 History of Changes |
| Other Study ID Numbers: | RA-TL011-101, 2009-015702-18 |
| Study First Received: | May 11, 2010 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Hungary: National Institute of Pharmacy |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013