An Open Label Study for Participants With Rheumatoid Arthritis

Lilly

Status and phase: Terminated; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: LY2127399

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215942

H9B-MC-BCDP (Other Identifier)

13419

Details and patient eligibility

About

The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up

Full description

Week 16 non-responders (NR) are participants with <20% improvement from baseline in both tender and swollen joint counts when assessed at Week 16 of Studies BCDO, BCDV and BCDM.

Enrollment: 1,086 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM
• Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion criteria

• Current presence of a serious disorder or illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,086 participants in 2 patient groups

120 milligrams (mg) of LY2127399

Experimental group

Description:

Given every 4 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 240 mg loading dose when initiating treatment. Or Given every 4 weeks for 168 weeks for those participants from Study BCDM.

Treatment:

Drug: LY2127399

90 mg LY2127399

Experimental group

Description:

Given every 2 weeks for 240 weeks for those participants from Study BCDO or Study BCDV. Participants who had been receiving placebo immediately prior to enrollment will receive a 180 mg loading dose when initiating treatment. Or Given every 2 weeks for 168 weeks for those participants from Study BCDM.

Treatment:

Drug: LY2127399