A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab (TCZ) — DRUG
  TCZ will be administered at a dose of 162 milligrams (mg) via SC injection weekly (if body weight is greater than or equal to \[\>/=\] 100 kilograms \[kg\]) or every 2 weeks (if body weight was less than \[\<\] 100 kg).
• Methotrexate (MTX) — DRUG
  MTX will be administered at a stable dose (15 mg to 25 mg per week) orally.
• Placebo (PBO) — DRUG
  PBO matching to MTX will be administered orally.

Study Details

This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose orally in an open-label manner for 24 weeks. Participants with a disease activity score based on 28 joints (DAS28) less than or equal to (\</=) 3.2 at Week 24, will be randomized to either continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52. Participants without a DAS28 score \</=3.2 at Week 24, will continue the same treatment in a non-randomized open-label manner up to Week 52.

Key Dates

Start date

Nov 7, 2013

Status verified

Nov 2017

Primary completion

Oct 14, 2016

Completion

Oct 14, 2016

Study Design

Enrollment

718 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Non-Randomized Participants (TCZ + MTX)
  All participants will receive initial treatment with open-label TCZ + MTX. Participants who complete 24-week treatment with open-label TCZ + MTX and did not achieve a DAS28 score \</=3.2 at Week 24, will continue receiving TCZ + MTX in open label manner up to Week 52.
• Experimental: Randomized Participants (TCZ + MTX)
  Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score \</=3.2 at Week 24, will be randomized to receive TCZ along with MTX up to Week 52.
• Active Comparator: Randomized Participants (TCZ + PBO)
  Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score \</=3.2 at Week 24, will be randomized to receive TCZ along with MTX matched placebo (PBO) up to Week 52.

Primary Outcome Measure

Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40 [ Time Frame: Week 24, Week 40 ]

Locations (155)

Find similar trials in Anniston, AL

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