NCT01862224

Brief Summary

The purpose of this study is to assess the impact of JNJ-38518168 on rheumatoid arthritis (RA) disease-related biomarkers in synovial biopsy tissue and blood in participants with active RA despite methotrexate (MTX) therapy and to assess the safety and tolerability of JNJ-38518168 over one year.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 9, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

May 2, 2013

Last Update Submit

June 12, 2015

Conditions

Rheumatoid Arthritis

Keywords

Active rheumatoid arthritis despite methotrexate therapyJNJ-38518168Synovial

Outcome Measures

Primary Outcomes (1)

  • Assessment of rheumatoid arthritis (RA) biomarkers

    Biomarkers may include, but are not limited to, inflammatory markers and cytokines; synovium/cartilage/bone markers; and gene expression profiles.

    Up to Week 52

Secondary Outcomes (1)

  • Number of participants reporting adverse events as a measure of safety and tolerability

    Up to Week 56

Study Arms (2)

JNJ-38518168

EXPERIMENTAL

JNJ-38518168 30 mg once daily for 52 weeks.

Drug: JNJ-38518168Drug: Methotrexate

Placebo/JNJ-38518168

PLACEBO COMPARATOR

Matching placebo once daily for 12 weeks followed by JNJ-38518168 30 mg once daily for 40 weeks.

Drug: JNJ-38518168Drug: PlaceboDrug: Methotrexate

Interventions

JNJ-38518168DRUG

JNJ-38518168 30 mg once daily, Week 0 to Week 52.

JNJ-38518168Placebo/JNJ-38518168
PlaceboDRUG

Matching placebo once daily (Week 0 to Week 12).

Placebo/JNJ-38518168
MethotrexateDRUG

All participants will continue receiving methotrexate up to Week 12. After Week 12, the dose of methotrexate may be adjusted as per Investigator's discretion.

JNJ-38518168Placebo/JNJ-38518168

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have had rheumatoid arthritis (RA) for at least 6 months prior to the date of signing the informed consent at screening
  • Be positive for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening
  • Have active RA defined for the purpose of this study as persistent disease activity with both of the following criteria: At least 4 swollen and 4 tender joints using a 66/68 joint count. At the time of screening, one of the tender or swollen joints or both must include the non-prosthetic knee to be biopsied; and serum C-reactive protein (CRP\_ ≥ 0.60 mg/dL at screening
  • Have been treated with and tolerated oral methotrexate (MTX) treatment at doses from 10 mg/week to 25 mg/week inclusive, for a minimum of 3 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0
  • If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain relievers) regularly for RA, the participant must have been on a stable dose for at least 2 weeks prior to the first administration of study agent. If not using NSAIDs or other analgesics for RA at Week 0, the participant must have not received NSAIDs or other analgesics for RA for at least 2 weeks prior to the first administration of study agent

You may not qualify if:

  • Has inflammatory diseases other than RA
  • Has a history of juvenile idiopathic arthritis (JIA)
  • Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Frederick, Maryland, United States

Location

Unknown Facility

Chisinau, Moldova

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 24, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 9, 2015

Record last verified: 2015-06

Locations

US(1)MO(1)