NCT01353859

Brief Summary

This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

5 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, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 6, 2014

Completed
Last Updated

June 6, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

May 13, 2011

Results QC Date

April 22, 2014

Last Update Submit

May 8, 2014

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Low Disease Activity Score

    Disease Activity Score using 28-Joint Count (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog scale \[VAS\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

    Week 24

Secondary Outcomes (9)

  • Time to Achieve Low Disease Activity (DAS28 ≤3.2)

    Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24

  • Percentage of Participants With a Clinically Significant Improvement in DAS28 Score

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

  • Time to Clinically Significant Improvement in DAS28

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

  • Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)

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

  • Time to Achieve DAS28 Remission (DAS28 <2.6)

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

  • +4 more secondary outcomes

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: tocilizumab [RoActemra/Actemra]Drug: methotrexate

Interventions

tocilizumab [RoActemra/Actemra]DRUG

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

Single Arm
methotrexateDRUG

10-25 mg orally weekly

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 (RA) of \>/= 6 months duration
  • Prior treatment with DMARDs for \>/= 12 weeks (at stable dose for \>/= 8 weeks)
  • Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)

You may not qualify if:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
  • Autoimmune disease other than RA
  • History of or current inflammatory joint disease other than RA
  • Previous treatment with any biologic drug that is used in the treatment of RA
  • Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
  • Impaired liver, renal or hematologic function
  • Active current or history of recurrent infection
  • History of or currently active primary or secondary immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Bandung, 40161, Indonesia

Location

Unknown Facility

Central Jakarta, 10430, Indonesia

Location

Unknown Facility

East Java, Indonesia

Location

Unknown Facility

Malang, 65111, Indonesia

Location

Unknown Facility

Yogyakarta, 55284, Indonesia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumabMethotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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 13, 2011

First Posted

May 16, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 6, 2014

Results First Posted

June 6, 2014

Record last verified: 2014-05

Locations

ID(5)