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An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ 38518168
Placebo
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, JNJ-38518168

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants diagnosed with rheumatoid arthritis (RA) according to the revised 1987 criteria of the ARA (Arnett et al, 1988) for at least 6 months at Screening
  • Participants who have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 milligram (mg) per week inclusive, for a minimum of 4 months before Screening
  • Participants if using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics (drug used to control pain) regularly for RA, participants must have been on a stable dose for at least 2 weeks before the first dose of study medication
  • Participants if using oral corticosteroids (compounds, usually hormonal, taken orally [by mouth] in order to block ovulation [discharge of an egg from the ovary] and prevent the occurrence of pregnancy [carrying an unborn baby]), must be on a stable dose of less than or equal to 10 mg per day of prednisone or another oral corticosteroid for at least 4 weeks before the first dose of study medication and continue with the same dose throughout the study. If not using corticosteroids at study initiation, the participant must have not received any oral corticosteroids for at least 4 weeks before the first dose of study medication
  • Participants currently treated with folic acid at a minimum dose of 5 mg per week

Exclusion Criteria:

  • Participants having inflammatory disease other than RA
  • Participant who have used any of the following medications: D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold salts, sulfasalazine, leflunomide, azathioprine, cyclosporine, tacrolimus, and mycophenolatemofetil
  • Participant who have received intra-articular, intramuscular (into the muscle), or intravenous (into the vein) corticosteroids, including adrenocorticotropic hormone (hormone made by the brain that activates the adrenal glands) within 4 weeks before the first dose of the study medication
  • Participants who have been treated with any other investigational drug or medical device within 4 weeks or 5 half-lives of the drug, whichever is longer before the first dose of study medication
  • Participants who have undergone surgical treatments for RA including synoviectomy (surgical removal of a part of the synovial membrane of a joint) and arthroplasty (surgery to fix a joint) within 3 months before the first dose of study medication

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JNJ-38518168

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Disease Activity Index Score (DAS28) C-Reactive Protein (CRP) at Week 12
The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.

Secondary Outcome Measures

Percentage of Participants With DAS28 (CRP) Response
The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, MCP1 to MCP5, proximal PIP, PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.
Percentage of Participants With DAS28 (ESR) Response
The DAS28 based on erythrocyte sedimentation rate (ESR) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR and global health (GH). The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).
Change From Baseline in DAS28 (ESR) Score at Week 12
The DAS28 based on ESR is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR, and GH. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).
Percentage of Participants Achieving American College of Rheumatology (ACR20) Response
The ACR20 response is defined as more than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter (mm), 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP.
Percentage of Participants Achieving ACR50 Response
The ACR50 response is defined as >=0 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of the following 5 assessments: participant's assessment of pain using VAS, participant's global assessment of disease activity by using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function as measured by HAQ-DI and CRP.
ACR-N Index Score
The ACR-N Index of improvement is defined as the minimum of the following 3 criteria: percent improvement from Baseline in tender joint counts, percent improvement from Baseline in swollen joint counts and median percent improvement from Baseline for the following 5 assessments: participant's assessment of pain using VAS, participant's global assessment of disease activity using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function as measured by HAQ-DI and CRP. Negative numbers indicate worsening.
Change From Baseline in HAQ-DI at Week 12
The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area).
Change From Baseline in Participant's Assessment of Pain at Week 12
Participants will assess their average pain on a VAS. The scale ranges from 0 mm to 100 mm, (0 mm=no pain to 100 mm=worst possible pain).
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
The Investigator's global disease assessments will be recorded on a VAS. The scale for the Investigator's assessments ranges from 0 mm to 100 mm (0 mm=no arthritis activity, 100 mm=extremely active arthritis).
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12
The participant's global disease assessments will be recorded on a VAS. The scale ranges from 0 mm to 100 mm (0 mm=very well to 100 mm=very poor).

Full Information

First Posted
July 16, 2009
Last Updated
April 22, 2013
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00941707
Brief Title
An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis
Official Title
A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to a single, unexpected serious event, the trial was stopped.
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis (long time systemic disease of the joints, marked by inflammatory changes in the synovial membranes and bones) despite methotrexate (MTX) therapy.
Detailed Description
This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) and parallel-group (each group of participants will be treated at the same time) study. The study will consist of 3 phases; Screening phase (3 weeks), Treatment phase (12 weeks) and Follow-up phase (4 weeks). Each participant will be enrolled in the study for approximately 19 weeks. Participants with active rheumatoid arthritis despite MTX therapy will receive JNJ-38518168, 100 milligram (mg) per day or matching placebo capsules once daily for 12 weeks. Efficacy will be primarily evaluated by change from Baseline in disease activity index score C-reactive protein at Week 12. Participants' safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, JNJ-38518168

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JNJ-38518168
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
JNJ 38518168
Intervention Description
JNJ-38518168 100 milligram (mg) capsules orally (by mouth) once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules matching to JNJ-38518168 orally once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Index Score (DAS28) C-Reactive Protein (CRP) at Week 12
Description
The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With DAS28 (CRP) Response
Description
The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, MCP1 to MCP5, proximal PIP, PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.
Time Frame
Week 12
Title
Percentage of Participants With DAS28 (ESR) Response
Description
The DAS28 based on erythrocyte sedimentation rate (ESR) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR and global health (GH). The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).
Time Frame
Week 12
Title
Change From Baseline in DAS28 (ESR) Score at Week 12
Description
The DAS28 based on ESR is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR, and GH. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving American College of Rheumatology (ACR20) Response
Description
The ACR20 response is defined as more than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter (mm), 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP.
Time Frame
Week 12
Title
Percentage of Participants Achieving ACR50 Response
Description
The ACR50 response is defined as >=0 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of the following 5 assessments: participant's assessment of pain using VAS, participant's global assessment of disease activity by using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function as measured by HAQ-DI and CRP.
Time Frame
Week 12
Title
ACR-N Index Score
Description
The ACR-N Index of improvement is defined as the minimum of the following 3 criteria: percent improvement from Baseline in tender joint counts, percent improvement from Baseline in swollen joint counts and median percent improvement from Baseline for the following 5 assessments: participant's assessment of pain using VAS, participant's global assessment of disease activity using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function as measured by HAQ-DI and CRP. Negative numbers indicate worsening.
Time Frame
Week 12
Title
Change From Baseline in HAQ-DI at Week 12
Description
The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area).
Time Frame
Baseline and Week 12
Title
Change From Baseline in Participant's Assessment of Pain at Week 12
Description
Participants will assess their average pain on a VAS. The scale ranges from 0 mm to 100 mm, (0 mm=no pain to 100 mm=worst possible pain).
Time Frame
Baseline and Week 12
Title
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
Description
The Investigator's global disease assessments will be recorded on a VAS. The scale for the Investigator's assessments ranges from 0 mm to 100 mm (0 mm=no arthritis activity, 100 mm=extremely active arthritis).
Time Frame
Baseline and Week 12
Title
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12
Description
The participant's global disease assessments will be recorded on a VAS. The scale ranges from 0 mm to 100 mm (0 mm=very well to 100 mm=very poor).
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants diagnosed with rheumatoid arthritis (RA) according to the revised 1987 criteria of the ARA (Arnett et al, 1988) for at least 6 months at Screening Participants who have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 milligram (mg) per week inclusive, for a minimum of 4 months before Screening Participants if using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics (drug used to control pain) regularly for RA, participants must have been on a stable dose for at least 2 weeks before the first dose of study medication Participants if using oral corticosteroids (compounds, usually hormonal, taken orally [by mouth] in order to block ovulation [discharge of an egg from the ovary] and prevent the occurrence of pregnancy [carrying an unborn baby]), must be on a stable dose of less than or equal to 10 mg per day of prednisone or another oral corticosteroid for at least 4 weeks before the first dose of study medication and continue with the same dose throughout the study. If not using corticosteroids at study initiation, the participant must have not received any oral corticosteroids for at least 4 weeks before the first dose of study medication Participants currently treated with folic acid at a minimum dose of 5 mg per week Exclusion Criteria: Participants having inflammatory disease other than RA Participant who have used any of the following medications: D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold salts, sulfasalazine, leflunomide, azathioprine, cyclosporine, tacrolimus, and mycophenolatemofetil Participant who have received intra-articular, intramuscular (into the muscle), or intravenous (into the vein) corticosteroids, including adrenocorticotropic hormone (hormone made by the brain that activates the adrenal glands) within 4 weeks before the first dose of the study medication Participants who have been treated with any other investigational drug or medical device within 4 weeks or 5 half-lives of the drug, whichever is longer before the first dose of study medication Participants who have undergone surgical treatments for RA including synoviectomy (surgical removal of a part of the synovial membrane of a joint) and arthroplasty (surgery to fix a joint) within 3 months before the first dose of study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Liege
Country
Belgium
City
Brno
Country
Czech Republic
City
Kladno
Country
Czech Republic
City
Praha 4
Country
Czech Republic
City
Uherske Hradiste
Country
Czech Republic
City
Zlin
Country
Czech Republic
City
Dublin 4
Country
Ireland
City
Pucheon
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
City
Amsterdam Zuidoost
Country
Netherlands
City
Bialystok
Country
Poland
City
Bydgoszcz N/A
Country
Poland
City
Elblag
Country
Poland
City
Lublin
Country
Poland
City
Torun
Country
Poland
City
Ekaterinburg
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Petrozavodsk
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Barcelona
Country
Spain
City
Guadalajara
Country
Spain
City
Santiago De Compostela
Country
Spain
City
Sevilla
Country
Spain
City
Changhua
Country
Taiwan
City
Taichung
Country
Taiwan
City
Taipei
Country
Taiwan
City
London
Country
United Kingdom
City
Middlesborough
Country
United Kingdom
City
Salford
Country
United Kingdom
City
Wigan
Country
United Kingdom

12. IPD Sharing Statement

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An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis

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