NCT01610791

Brief Summary

This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P25-P50 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

8 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

March 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 10, 2014

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

1.4 years

First QC Date

May 31, 2012

Results QC Date

May 7, 2014

Last Update Submit

July 8, 2014

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Adverse Events

    Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.

    Baseline, Weeks 4, 8, 12, 16, 20, and 24

Secondary Outcomes (17)

  • Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit

    Weeks 4, 8, 12, 16, 20, and 24

  • Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value

    Baseline through Week 24

  • Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values

    Baseline through Week 24

  • Percentage of Participants With Lipid Elevations by Study Visit

    Baseline, Weeks 4, 8, 12, 16, 20, and 24

  • Disease Activity Score Based on 28-Joint Count (DAS28)

    Baseline, Weeks 4, 8, 12, 16, 20, and 24

  • +12 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra]DRUG

8 mg/kg iv every 4 weeks, total of 6 infusions

Single Arm

Eligibility Criteria

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

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Moderate to severe active rheumatoid arthritis (DAS28 \> 3.2 at screening)
  • Inadequate response to DMARDs
  • Body weight \< 150 kg

You may not qualify if:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
  • Rheumatic autoimmune disease other than RA
  • American College of Rheumatology (ACR) functional class IV
  • Prior history of or current inflammatory joint disease other than RA
  • Previous treatment with any biologic drug that is used in the treatment of RA
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Pregnant or lactating women
  • Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Casablanca, 20000, Morocco

Location

Unknown Facility

Fés, 30000, Morocco

Location

Unknown Facility

Kenitra, 25000, Morocco

Location

Unknown Facility

Khouribga, 14000, Morocco

Location

Unknown Facility

Marrakesh, 40000, Morocco

Location

Unknown Facility

Meknés, 50000, Morocco

Location

Unknown Facility

Rabat, 10000, Morocco

Location

Unknown Facility

Salé, 15045, Morocco

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann- LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 4, 2012

Study Start

March 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 10, 2014

Results First Posted

July 10, 2014

Record last verified: 2014-07

Locations

MO(8)