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A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate

Primary Purpose

Active Rheumatoid Arthritis; Rheumatoid Arthritis

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Placebo/JNJ-39758979 (300 mg/d)

JNJ-39758979 (10 mg)

JNJ-39758979 (30 mg)

JNJ-39758979 (100 mg)

JNJ-39758979 (300 mg)

About this trial

This is an interventional treatment trial for Active Rheumatoid Arthritis; Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, Swollen and tender joints, Dose range finding study, Concurrent treatment with methotrexate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Has a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening.
Positive test for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening.
Has active RA defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints, and serum CRP ≥ 0.70 mg/dL at screening.
Has been treated with and tolerated methotrexate (MTX) treatment at dosages of 10 to 25 mg/week for a minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8 weeks prior to screening
Must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control
Has completed at least 5 days of daily pain diary in the 10 days prior to randomization.

Exclusion Criteria:

Has inflammatory diseases other than RA, such as Lupus.
Is currently receiving treatment for RA other than methotrexate, NSAIDS, or oral corticosteroids such as prednisone, or pain medicines.
Has ever received any biologic agent for a rheumatic indication.
Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
Has moderate or severe renal insufficiency
Has a recent (within 2 months) serious infection
Has had an opportunistic infection.
Has had cancer within the past 5 years (except certain skin or cervical conditions)
Has abused substances or alcohol within the past 2 years
Has active Hepatitis B or C infection
Has had active tuberculosis
Has had exposure to tuberculosis without preventative treatment

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

JNJ-39758979 (10 mg/d)

JNJ-39758979 (30 mg/d)

JNJ-39758979 (100 mg/d)

JNJ-39758979 (300 mg/d)

Arm Description

Outcomes

Primary Outcome Measures

The primary end point is change from baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12

Secondary Outcome Measures

Change from baseline in DAS28 (CRP) at Week 24

Change from baseline in DAS28 (ESR) at Week 12 and Week 24

DAS28 (CRP) response rates at Week 12 and Week 24

DAS28 (ESR) response rates at Week 12 and Week 24

DAS28 (CRP) remission rates at Week 12 and Week 24

American college of rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24

Hybrid ACR response at Week 12 and Week 24

ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24

Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24

Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24

Health Assessment Questionnaire - Disability Index (HAQ-DI) response at Week 12 and Week 24

Change from baseline in HAQ-DI score at Week 12 and Week 24

Percent change from baseline in ESR levels at Week 12 and Week 24

Percent change from baseline in ACR components at Week 12 and Week 24

Full Information

NCT ID

NCT01480388

First Posted

November 23, 2011

Last Updated

November 30, 2016

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01480388

Brief Title

A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate

Official Title

A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Study was terminated prematurely due to 2 cases of agranulocytosis in a different clinical trial with this same drug.

Study Start Date

December 2011 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to assess the efficacy, safety and tolerability of JNJ-39758979 at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance) in patients with active rheumatoid arthritis despite concomitant treatment with methotrexate (MTX).

Detailed Description

This is a double-blind (neither physician nor patient knows if the patient is receiving JNJ-39758979 or placebo), multicenter, randomized (patients are assigned to treatment by chance), placebo-controlled, dose range finding study of JNJ-39758979 in patients with stable methotrexate treatment through Week 24. The study will consist of 4 periods: a screening period, a 24-week placebo-controlled period, a 24-week extension period, and a 5-week safety follow-up period. The duration of participation in the study for an individual patient will be up to 59 weeks (including screening). All patients will be randomly assigned in a 1:1:1:1:1 ratio to receive placebo or JNJ-39758979 10 mg, 30 mg, 100 mg, or 300 mg once daily. At Week 24, all patients remaining in the placebo group will start to receive JNJ-39758979 300 mg/day. Safety assessments and evaluations to determine the efficacy of JNJ-39758979 to reduce the signs and symptoms of rheumatoid arthritis will be performed at study visits. The extension and safety follow-up periods of this study will continue through Week 53 in order to assess the safety and for maintenance of efficacy of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Active Rheumatoid Arthritis; Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Swollen and tender joints, Dose range finding study, Concurrent treatment with methotrexate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

JNJ-39758979 (10 mg/d)

Arm Type

Experimental

Arm Title

JNJ-39758979 (30 mg/d)

Arm Type

Experimental

Arm Title

JNJ-39758979 (100 mg/d)

Arm Type

Experimental

Arm Title

JNJ-39758979 (300 mg/d)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Placebo/JNJ-39758979 (300 mg/d)

Other Intervention Name(s)

Inactive medical substance

Intervention Description

Form = tablet, route = oral adminstration placebo once daily from Week 0 to Week 24 followed by JNJ-39758979 300 mg once daily from Week 24 to Week 48.

Intervention Type

Drug

Intervention Name(s)

JNJ-39758979 (10 mg)

Intervention Description

Form = tablet, route = oral adminstration once daily up to 48 weeks

Intervention Type

Drug

Intervention Name(s)

JNJ-39758979 (30 mg)

Intervention Description

Form = tablet, route = oral adminstration once daily up to 48 weeks

Intervention Type

Drug

Intervention Name(s)

JNJ-39758979 (100 mg)

Intervention Description

Form = tablet, route = oral adminstration once daily up to 48 weeks

Intervention Type

Drug

Intervention Name(s)

JNJ-39758979 (300 mg)

Intervention Description

Form = tablet, route = oral adminstration once daily for 48 weeks

Primary Outcome Measure Information:

Title

The primary end point is change from baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change from baseline in DAS28 (CRP) at Week 24

Time Frame

Baseline, Week 24

Title

Change from baseline in DAS28 (ESR) at Week 12 and Week 24

Time Frame

Baseline, Week 12 and Week 24

Title

DAS28 (CRP) response rates at Week 12 and Week 24

Time Frame

Week 12, Week 24

Title

DAS28 (ESR) response rates at Week 12 and Week 24

Time Frame

Week 12, Week 24

Title

DAS28 (CRP) remission rates at Week 12 and Week 24

Time Frame

Week 12, Week 24

Title

American college of rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24

Time Frame

Week 12, Week 24

Title

Hybrid ACR response at Week 12 and Week 24

Time Frame

Week 12, Week 24

Title

ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24

Time Frame

Week 12, Week 24

Title

Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24

Time Frame

Baseline, Week 12, Week 24

Title

Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24

Time Frame

Baseline, Week 12, Week 24

Title

Health Assessment Questionnaire - Disability Index (HAQ-DI) response at Week 12 and Week 24

Time Frame

Week 12, Week 24

Title

Change from baseline in HAQ-DI score at Week 12 and Week 24

Time Frame

Baseline, Week 12 and Week 24

Title

Percent change from baseline in ESR levels at Week 12 and Week 24

Time Frame

Baseline, Week 12 and Week 24

Title

Percent change from baseline in ACR components at Week 12 and Week 24

Time Frame

Baseline, Week 12 and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening. Positive test for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening. Has active RA defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints, and serum CRP ≥ 0.70 mg/dL at screening. Has been treated with and tolerated methotrexate (MTX) treatment at dosages of 10 to 25 mg/week for a minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8 weeks prior to screening Must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control Has completed at least 5 days of daily pain diary in the 10 days prior to randomization. Exclusion Criteria: Has inflammatory diseases other than RA, such as Lupus. Is currently receiving treatment for RA other than methotrexate, NSAIDS, or oral corticosteroids such as prednisone, or pain medicines. Has ever received any biologic agent for a rheumatic indication. Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled. Has moderate or severe renal insufficiency Has a recent (within 2 months) serious infection Has had an opportunistic infection. Has had cancer within the past 5 years (except certain skin or cervical conditions) Has abused substances or alcohol within the past 2 years Has active Hepatitis B or C infection Has had active tuberculosis Has had exposure to tuberculosis without preventative treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Development, L.L.C. Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate

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