A Study to Assess the Safety and Efficacy of Tocilizumab... | NCT00109408

Studies
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

NCT00109408

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

673Actual

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

Methotrexate
tocilizumab [RoActemra/Actemra]

Countries

United States
Argentina
Australia
Canada
China
Denmark
France
Israel
Italy
Lithuania
Mexico
Norway
Peru
Portugal
Serbia
Slovenia
South Africa
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Apr 27, 2005

First Submission Date that Met QC Criteria

Apr 27, 2005

First Posted Date

Apr 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

673Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: tocilizumab [RoActemra/Actemra]
2	Active Comparator		Drug: Methotrexate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methotrexate	Drug	7.5-20mg po weekly	2
tocilizumab [RoActemra/Actemra]

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with ACR 20 response		Week 24

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients with ACR 20 response		Week 8
Percentage of patients with ACR 50 and ACR 70 responses		Week 24
Mean change in parameters of ACR core set

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients at least 18 years of age with active RA for at least 3 months;
patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
treatment with methotrexate (MTX) within 6 months of entering study;
patients who have stopped previous MTX treatment due to toxicity or lack of response;
women who are pregnant or breast-feeding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Montgomery	Alabama	36111	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33413588	Derived	Drobinski PJ, Bay-Jensen AC, Karsdal MA, Sardar S, Siebuhr AS. Connective tissue remodelling is differently modulated by tocilizumab versus methotrexate monotherapy in patients with early rheumatoid arthritis: the AMBITION study. Arthritis Res Ther. 2021 Jan 7;23(1):13. doi: 10.1186/s13075-020-02378-7.
28955499	Derived

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds