An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: CNTO 6785 100 mg; Drug: CNTO 6785 50 mg; Drug: CNTO 6785 15 mg; Drug: CNTO 6785 200 mg; Drug: Methotrexate (MTX)

• Registration Number: NCT01909427
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

Detailed Description

This is a randomized (participants are assigned to treatment by chance), double-blind (participants and study personnel will not know which treatments are being given), placebo-controlled (a placebo appears identical to a study drug but has no active ingredients), multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. Approximately 250 participants with active RA despite MTX therapy will be randomly assigned to receive placebo or CNTO 6785 during the double-blind treatment phase. The maximum period of active treatment will be 28 weeks. The maximum duration of study participation will be 44 weeks. Participant safety will be monitored throughout the study.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-26
• Primary Completion: 2014-12
• Study Completion: 2015-05
• Disposition First Submitted: 2015-12-18
• Disposition First Submitted QC: 2015-12-18
• Disposition First Posted: 2016-01-22
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

• Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
• Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
• Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent

Exclusion Criteria

• Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
• Has a diagnosis of fibromyalgia
• Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
• At screening, the results of laboratory tests must meet protocol-specified criteria
• Has ever received any approved or investigational biologic agent for a rheumatic indication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/CNTO 6785 200 mg+Methotrexate (MTX)	Placebo	-
Placebo/CNTO 6785 200 mg+Methotrexate (MTX)	CNTO 6785 200 mg	-
Placebo/CNTO 6785 200 mg+Methotrexate (MTX)	Methotrexate (MTX)	-
CNTO 6785 200 mg+MTX	CNTO 6785 200 mg	-
CNTO 6785 200 mg+MTX	Methotrexate (MTX)	-
CNTO 6785 100 mg+MTX	CNTO 6785 100 mg	-
CNTO 6785 50 mg+MTX	CNTO 6785 50 mg	-
CNTO 6785 15 mg+MTX	CNTO 6785 15 mg	-
CNTO 6785 100 mg+MTX	Methotrexate (MTX)	-
CNTO 6785 50 mg+MTX	Methotrexate (MTX)	-
CNTO 6785 15 mg+MTX	Methotrexate (MTX)	-

Primary Outcome Measures

Name	Time	Method
The proportion of participants who achieve an ACR 20 response at Week 16	Week 16	American College of Rheumatology (ACR) 20 response is a \>=20% improvement in rheumatoid arthritis (RA) symptoms.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in DAS28 (CRP) at Week 16	Baseline to Week 16	DAS28 (using CRP \[C-reactive protein\]) is a measure of tender and swollen joints and the patient's assessment of disease activity.
The proportion of participants who achieve ACR 50 response at Week 16	Week 16	American College of Rheumatology (ACR) 50 response is a \>=50% improvement in rheumatoid arthritis (RA) symptoms.
The proportion of participants who achieve ACR 20 response through Week 32	Week 32
The proportion of participants who achieve ACR 50 response through Week 32	Week 32
The proportion of participants who achieve ACR 70 response through Week 32	Week 32	American College of Rheumatology (ACR) 70 response is a \>=70% improvement in rheumatoid arthritis (RA) symptoms.
Change from baseline of DAS28 (CRP) through Week 32	Baseline to Week 32
The proportion of participants with DAS28 (CRP) response through Week 32	Week 32	DAS28 (using CRP \[C-reactive protein\]) response is improvement from baseline, with \>1.2 indicating a good or moderate response and \<=0.6 indicating no response.
Change from baseline in DAS28 (ESR) at Week 32	Baseline to Week 32
Change from baseline in HAQ-DI score through Week 32	Baseline to Week 32	The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas, each scored from 0 (no difficulty) to 3 (inability to perform a task).
The proportion of participants with DAS28 (CRP) remission at Week 16	Week 16	DAS28 (using CRP \[C-reactive protein\]) remission is defined as a value of \<2.6 on the Disease Activity Index, a measure of tender and swollen joints and the patient's assessment of disease activity.
The proportion of participants with DAS28 (CRP) remission at Week 32	Week 32
Change from baseline in DAS28 (ESR) at Week 16	Baseline to Week 16	DAS28 (using erythrocyte sedimentation rate) is a measure of tender and swollen joints and the patient's assessment of disease activity.
Change from baseline in CDAI at Week 32	Baseline to Week 32
The proportion of participants with Boolean-based ACR/EULAR remission at Week 16	Week 16	Boolean-based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) \<=1; swollen joint count (66 joints) \<=1; CRP \<=1 mg/dL; and Patient's Global Assessment of Disease Activity on VAS \<=1 on a 0 to 10 scale.
The proportion of participants with Boolean-based ACR/EULAR remission at Week 32	Week 32
Change from baseline in SDAI at Week 16	Baseline to Week 16	The Simplified Disease Activity Index (SDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, Physician's Global Assessments of Disease Activity, and CRP.
Change from baseline in SDAI at Week 32	Baseline to Week 32
The proportion of participants with SDAI-based ACR/EULAR remission at Week 16	Week 16	The Simplified Disease Activity Index (SDAI)-based ACR/EULAR (European League Against Rheumatism) remission is defined as a SDAI value of \<=3.3 at a visit.
The proportion of participants with SDAI-based ACR/EULAR remission at Week 32	Week 32
Change from baseline in SF-36 at Week 16	Baseline to Week 16	The SF-36 is a medical outcome study health measure and consists of 8 multi-item scales that are scored from 0 to 100, with higher scores indicating better health.
Change from baseline in CDAI at Week 16	Baseline to Week 16	Clinical Disease Activity Index (CDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, and Physician's Global Assessments of Disease Activity.
Change from baseline in SF-36 at Week 32	Baseline to Week 32