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A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

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Roche

Status and phase

Completed
Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01089023
ML22440

Details and patient eligibility

About

This open-label single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab [RoActemra/Actemra] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients, >/=18 years of age
  • moderate to severe rheumatoid arthritis (DAS28 >3.2) of 6 months duration
  • inadequate clinical response to non-biologic DMARDs or anti-TNF
  • bodyweight </=150 kg

Exclusion criteria

  • rheumatic autoimmune disease or inflammatory joint disease other than RA
  • major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

95 participants in 1 patient group

1
Experimental group
Treatment:
Drug: tocilizumab [RoActemra/Actemra]

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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