NCT01587989

Brief Summary

This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

13 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 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 17, 2015

Completed
Last Updated

July 17, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

March 12, 2012

Results QC Date

June 22, 2015

Last Update Submit

June 22, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change From Week 12 (Randomization) to Week 24 in DAS28

    The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* GH in mm visual analogue assessment (VAS)\]. A negative change from randomization indicated improvement.

    Weeks 12 and 24

Secondary Outcomes (8)

  • Percentage of Participants With DAS28 Remission at Week 24

    Week 24

  • vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24

    Week 24

  • Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24

    Week 24

  • Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24

    Week 24

  • Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

    Weeks 12 and 24

  • +3 more secondary outcomes

Study Arms (2)

A Methotrexate

ACTIVE COMPARATOR
Drug: methotrexateDrug: tocilizumab [RoActemra/Actemra]

B Methotrexate Placebo

EXPERIMENTAL
Drug: methotrexateDrug: placeboDrug: tocilizumab [RoActemra/Actemra]

Interventions

methotrexateDRUG

15-25 mg orally weekly, Weeks 1-12

A MethotrexateB Methotrexate Placebo
placeboDRUG

methotrexate placebo orally weekly, Weeks 13-24

B Methotrexate Placebo
tocilizumab [RoActemra/Actemra]DRUG

8 mg/kg iv every 4 weeks, 24 weeks

A MethotrexateB Methotrexate Placebo

Eligibility Criteria

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

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Rheumatoid arthritis of \>/= 1 year duration
  • Mild to moderate disease activity at screening (DAS 28 \</= 4.5 and \>2.6)
  • On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
  • Body weight \</= 150 kg
  • Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline

You may not qualify if:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • Functional class IV American College of Rheumatology (ACR) Classification
  • Prior history of or current inflammatory joint disease other than rheumatoid arthritis
  • Treatment with a biologic agent at any time prior to baseline
  • Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Previous treatment with tocilizumab
  • Pregnant or lactating women
  • Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
  • History of or currently active primary or secondary immunodeficiency
  • Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
  • Active tuberculosis requiring treatment within the previous 3 years
  • Positive for HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Graz, 8036, Austria

Location

Unknown Facility

Graz-Eggenberg, 8020, Austria

Location

Unknown Facility

Hollabrunn, 2020, Austria

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Linz, 4020, Austria

Location

Unknown Facility

Salzburg, 5020, Austria

Location

Unknown Facility

Stockerau, 2000, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Vienna, 1100, Austria

Location

Unknown Facility

Vienna, 1130, Austria

Location

Unknown Facility

Vienna, 1140, Austria

Location

Unknown Facility

Vienna, 1160, Austria

Location

Unknown Facility

Wels, 4600, Austria

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexatetocilizumab

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
Hoffman-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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

April 30, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

July 17, 2015

Results First Posted

July 17, 2015

Record last verified: 2015-06

Locations

AU(13)