Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01008852

Enrollment

210

Registered

2009-11-06

Start date

2009-12-31

Completion date

2013-07-31

Last updated

2013-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Rheumatoid Arthritis

Keywords

rheumatoid arthritis, seropositive, methotrexate

Brief summary

This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.

Interventions

DRUGSBI-087

200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

DRUGPlacebo

Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening * Active RA as defined by \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein \>= 10 mg/L or Erythrocyte Sedimentation Rate \>= 28 mm/h * Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity * Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

Exclusion criteria

* Any significant health problem other than rheumatoid arthritis * Any clinically significant laboratory abnormalities * Any prior use of B cell-depleting therapy

Design outcomes

Primary

Measure	Time frame
Response as measured by American College of Rheumatology criteria (ACR 20 response)	16 weeks

Secondary

Measure	Time frame
ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response	up to 24 weeks

Countries

Argentina, Canada, Chile, Hungary, Japan, Mexico, Poland, Serbia, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026