NCT01123070

Brief Summary

The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Feb 2010

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
5 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2012

Completed
9.5 years until next milestone

Results Posted

Study results publicly available

October 4, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

May 11, 2010

Results QC Date

July 22, 2021

Last Update Submit

September 7, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B

    Day 1 to Day 57

Secondary Outcomes (8)

  • Maximum Observed Concentration (Cmax) in Part B

    Day 1 to Day 57

  • Number of Participants With Adverse Events in Part B

    From randomization up to Week 24

  • Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B

    Day 1, Day 15

  • AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B

    Day 1, Day 15

  • Percent Change From Baseline in CD19+ B-cell Count in Part B

    Baseline to Day 57

  • +3 more secondary outcomes

Study Arms (2)

TL011

EXPERIMENTAL

TL011 infusions

Biological: TL011, anti CD20, for the treatment of rheumatoid arthritis

MabThera

ACTIVE COMPARATOR

MabThera infusions

Biological: MabThera infusions

Interventions

TL011, anti CD20, for the treatment of rheumatoid arthritisBIOLOGICAL

TL011 administered by 2 infusions, 2 weeks apart

TL011
MabThera infusionsBIOLOGICAL

MabThera, administered by 2 infusions, 2 weeks apart

MabThera

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Rheumatic autoimmune disease other than RA
  • Active infection
  • Known immunodeficiency syndrome
  • Positive Hepatitis B surface antigen or antibodies to Hepatitis C
  • History of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Teva Investigational Site 5428

Pilsen, 323 00, Czechia

Location

Teva Investigational Site 5426

Prague, 12850, Czechia

Location

Teva Investigational Site 5429

Uherské Hradiště, 686 01, Czechia

Location

Teva Investigational Site 5123

Budapest, 1083, Hungary

Location

Teva Investigational Site 5122

Budapest, H-1023, Hungary

Location

Teva Investigational Site 5125

Debrecen, 4032, Hungary

Location

Teva Investigational Site 5124

Szeged, H-6720, Hungary

Location

Teva Investigational Site 3077

Florence, 50139, Italy

Location

Teva Investigational Site 3075

Genova, 16132, Italy

Location

Teva Investigational Site 3078

Pavia, 27100, Italy

Location

Teva Investigational Site 3076

Siena, 53100, Italy

Location

Teva Investigational Site 3170

Barakaldo, 48903, Spain

Location

Teva Investigational Site 3168

Guadalajara, 19002, Spain

Location

Teva Investigational Site 3167

Madrid, 28009, Spain

Location

Teva Investigational Site 3169

Seville, 41014, Spain

Location

Teva Investigational Site 3434

Manchester, M13 9WL, United Kingdom

Location

Teva Investigational Site 3433

Staffordshire, WS11 5XY, United Kingdom

Location

Teva Investigational Site 3435

Wirral, Merseyside, CH49 5PE, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Director, Clinical Research
Organization
Teva Branded Pharmaceutical Products R&D, Inc.
USMedInfo@tevapharm.com
1-888-483-8270

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 14, 2010

Study Start

February 5, 2010

Primary Completion

April 23, 2012

Study Completion

April 23, 2012

Last Updated

October 4, 2021

Results First Posted

October 4, 2021

Record last verified: 2021-09

Locations

IT(4)ES(4)GB(3)CZ(3)HU(4)