Clinical trial NCT02379091
Conditions: Rheumatoid Arthritis
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-12-17; Completion date: 2016-12-05
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish proof of concept and identify the optimal efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor (TNF)-inhibitor (TNF-IR).

Detailed description:
The drug being tested in this study is called namilumab. Namilumab is being tested to treat rheumatoid arthritis (RA) in people who have an inadequate response to methotrexate, and in people who have an inadequate response to tumor necrosis factor-inhibitor (TNF-IR). This study will look at improvement in disease activity in participants who take namilumab.

The study will enroll approximately 100 patients. Participants will be randomly assigned (by chance) to one of the four treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

* Namilumab 20 mg/mL subcutaneous injection
* Namilumab 80 mg/mL subcutaneous injection
* Namilumab 150 mg/mL subcutaneous injection
* Placebo (dummy inactive subcutaneous injection) - this is a medication that looks like the study drug but has no active ingredient.

All participants will receive namilumab or placebo as specified in the protocol. A stable dose of methotrexate and daily folic acid will also be required treatments.

This multi-centre trial will be conducted worldwide. The overall time to participate in this study is up to approximately 40 weeks. Participants will make multiple visits to the clinic, including a follow-up assessment up to 18 weeks after the last dose of study medication.

Arms: arm 1: Namilumab placebo-matching, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. arm 2: Namilumab 20 mg/mL, subcutaneous (SC) injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. arm 3: Namilumab 80 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant entered an open-label period and received namilumab 150 mg/mL, SC injection, every 4 Weeks up to Week 24. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study. arm 4: Namilumab 150 mg/mL, SC injection, once on Days 1, 15, 43, 71 and every 4 weeks for 12 Weeks. Participants were assessed for response (a 20% improvement from Baseline in both swollen and tender joint counts). If the participant was a responder, the current treatment continued every 4 weeks up to Week 24. If the participant was a non-responder, the participant was discontinued from the study. All participants were on a stable dose of methotrexate tablets (15-25 mg weekly) and folic acid (at least 5 mg/week) orally throughout the duration of the study.
Interventions: intervention 1: Namilumab intervention 2: Placebo intervention 3: Methotrexate intervention 4: Folic/folinic acid
Intervention descriptions: intervention 1: Namilumab subcutaneous injection intervention 2: Namilumab placebo-matching subcutaneous injection intervention 3: Methotrexate tablets intervention 4: Folic/folinic acid tablets

Protocol documents: