NCT01878318

Brief Summary

This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2013

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 14, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

June 6, 2013

Last Update Submit

November 1, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale

    from baseline to Week 24

Secondary Outcomes (10)

  • Radiological changes in the hand according to the modified Sharp scale

    from baseline to Week 24

  • Change in Ritchie articular index

    from baseline to Week 24

  • Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24

    Weeks 12 and 24

  • Change in pain: Visual analogue scale (VAS)

    from baseline to Week 24

  • Change in disability: Stanford Health Assessment Questionnaire

    from baseline to Week 24

  • +5 more secondary outcomes

Study Arms (1)

RoActemra/Actemra

EXPERIMENTAL
Drug: methotrexateDrug: tocilizumab [RoActemra/Actemra]

Interventions

methotrexateDRUG

stable dose

RoActemra/Actemra
tocilizumab [RoActemra/Actemra]DRUG

8 mg/kg intravenously every 4 weeks, 24 weeks

RoActemra/Actemra

Eligibility Criteria

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

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of \>/= 6 months duration
  • Active moderate to severe rheumatoid arthritis (DAS \>/= 3.2)
  • Swollen joint count (SJC) \>/= 6, tender joint count \>/= 8
  • Synovitis in the dominant hand
  • Inadequate response to stable dose of a non-biological DMARD for at least 3 months
  • Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
  • Patient on outpatient treatment

You may not qualify if:

  • Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization
  • Rheumatic autoimmune disease other than rheumatoid arthritis
  • American College of Rheumatology (ACR) functional class IV
  • History of or current inflammatory joint disease other than rheumatoid arthritis
  • Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
  • Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
  • Inadequate hematologic, renal or liver function
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Pregnant or lactating women
  • History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
  • Current infections or history of recurrent infections
  • History of or currently active primary or acquired immunodeficiency
  • Active tuberculosis requiring treatment in the previous 3 years
  • Body weight \> 150 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2013

First Posted

June 14, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11