NCT00965653

Brief Summary

This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is \< 50 individuals.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Aug 2009

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
3 countries

7 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

August 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

First QC Date

August 18, 2009

Last Update Submit

November 1, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics of TCZ after QW or Q2W sc administration

    multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up

  • Pharmacodynamic responses of CRP

    sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment

  • Safety and tolerability, including injection site reaction

    laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.

Secondary Outcomes (2)

  • Efficacy according to ACR and DAS-EULAR parameters

    assessments on day 1 of weeks 1, 4, 8 and 12

  • PD responses of IL-6, sIL-6R and anti TCZ antibody

    multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up

Study Arms (2)

1

EXPERIMENTAL
Drug: folic acidDrug: methotrexateDrug: tocilizumab [RoActemra/Actemra]

2

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

Interventions

folic acidDRUG

\>/= 5 mg po weekly

12
methotrexateDRUG

7.5 - 25 mg weekly (oral or parenteral)

12
tocilizumab [RoActemra/Actemra]DRUG

162 mg sc weekly (QW)for 12 weeks

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults 18 - 75 years of age
  • active rheumatoid arthritis of \>/= 6 months duration
  • inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
  • swollen joint count (SJC)\>/=4, tender joint count (TJC)\>/=6 at screening and baseline
  • DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
  • oral corticosteroids (\</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose \</= 4 weeks prior to baseline

You may not qualify if:

  • rheumatic autoimmune disease other than rheumatoid arthritis
  • prior history or current inflammatory joint disease other than rheumatoid arthritis
  • major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
  • functional class IV by ACR classification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

St. John's, Newfoundland and Labrador, A1A 5E8, Canada

Location

Unknown Facility

Kitchener, Ontario, N2M 5N6, Canada

Location

Unknown Facility

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

Unknown Facility

Christchurch, 8011, New Zealand

Location

Unknown Facility

A Coruña, La Coruña, 15006, Spain

Location

Unknown Facility

Santiago de Compostela, La Coruña, 15706, Spain

Location

Unknown Facility

Seville, Sevilla, 41009, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Folic AcidMethotrexatetocilizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAminopterin

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 25, 2009

Study Start

August 1, 2009

Study Completion

July 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CA(3)NZ(1)ES(3)