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Rheumatoid ArthritisPhase 2NCT01679951

A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate

A Phase 2 study testing JNJ-38518168 (3 mg), JNJ-38518168 (10 mg) and JNJ-38518168 (30 mg) in people with Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 85 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
JNJ-38518168 (3 mg), JNJ-38518168 (10 mg) and JNJ-38518168 (30 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
85 sitesin 16 countries
Study dates
31 Oct 2012to 3 Jul 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has had rheumatoid arthritis for at least 6 months prior to the date of signing the informed consent at screening
  • Must be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening
  • Must have active rheumatoid arthritis (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 greater than or equal to 0.80 mg/dL at the time of screening
  • Has been treated with and tolerated methotrexate treatment at dosages from 10 to 25 mg/week inclusive, for a minimum of 6 months with stable dose for at least 8 weeks prior to the date of signing the informed consent at screening

Who cannot join

  • Has inflammatory diseases other than rheumatoid arthritis, including but not limited to adult onset Still's disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy
  • 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
  • Has ever received any approved or investigational biologic agent for a rheumatoid indication
  • Has been treated with any nonbiologic disease modifying antirheumatic drugs within 4 weeks prior to the first administration of study agent

Trial locations and contacts

85 sites in 16 countries.

85 sites in 16 countries

Japan13 sites

  • Study site

    Chiba

  • Study site

    Fukuoka

  • Study site

    Hokkaido

  • Study site

    Kanagawa

  • Study site

    Katō

  • Study site

    Kawagoe

  • Study site

    Kumamoto

  • Study site

    Kyoto

  • Study site

    Matsuyama

  • Study site

    Osaka

  • Study site

    Sapporo

  • Study site

    Takasaki

  • Study site

    Tokyo

Other trials in Japan

United States9 sites

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Covina, California

  • Study site

    Frederick, Maryland

  • Study site

    Freehold, New Jersey

  • Study site

    Gilbert, Arizona

  • Study site

    Granger, Indiana

  • Study site

    Huntsville, Alabama

  • Study site

    Palm Harbor, Florida

Other trials in United States

Mexico9 sites

  • Study site

    Del Gustavo A Madero

  • Study site

    Delegación Cuauhtémoc

  • Study site

    Guadalaja

  • Study site

    Guadalajara

  • Study site

    Guadalajara, Jalisco

  • Study site

    León

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    San Luis Potosí City

Other trials in Mexico

Russia8 sites

  • Study site

    Kazan'

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Petrozavodsk

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Tver'

  • Study site

    Yaroslavl

Other trials in Russia

Poland7 sites

  • Study site

    Bialystok

  • Study site

    Katowice

  • Study site

    Nadarzyn

  • Study site

    Poznan

  • Study site

    Środa Wielkopolska

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Colombia5 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Bucaramanga

  • Study site

    Cali

  • Study site

    Medellín

Other trials in Colombia

Czechia5 sites

  • Study site

    Hlučín

  • Study site

    Ostrava

  • Study site

    Prague

  • Study site

    Slaný

  • Study site

    Zlín

Other trials in Czechia

Hungary5 sites

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Gyulai

  • Study site

    Veszprém

Other trials in Hungary

Chile4 sites

  • Study site

    Osorno X Region

  • Study site

    Santiago

  • Study site

    Santiago - Macul

  • Study site

    Viña del Mar

Other trials in Chile

Romania4 sites

  • Study site

    Bacau

  • Study site

    Brăila

  • Study site

    Bucharest

  • Study site

    Sibiu

Other trials in Romania

Latvia3 sites

  • Study site

    Adazi

  • Study site

    Riga

  • Study site

    Valmiera

Other trials in Latvia

South Korea3 sites

  • Study site

    Daegu

  • Study site

    Pucheon

  • Study site

    Suwon

Other trials in South Korea

Taiwan3 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Taipei

Other trials in Taiwan

Ukraine3 sites

  • Study site

    Donetsk

  • Study site

    Kyiv

  • Study site

    Vinnytsia

Other trials in Ukraine

Argentina2 sites

  • Study site

    Buenos Aires

  • Study site

    San Miguel de Tucumán

Other trials in Argentina

Thailand2 sites

  • Study site

    Bangkok

  • Study site

    Chiang Mai

Other trials in Thailand

About this study

Official title: A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Dose Range Finding Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.

Read the detailed description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), multicenter, placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each group of patients will be treated at the same time), dose range finding study of JNJ-38518168 in patients with active RA despite concomitant MTX therapy. The study will consist a screening period, a 24-week placebo-controlled period and a 4-week follow-up period between the last dose and the last visit. The duration of participation in the study for an individual patient will be up to 34 weeks (including screening). The patients will be assigned to 1 of 4 treatment groups in a 1:1:1:1 ratio to placebo and JNJ-38518168 (3 mg or 10 mg or 30 mg). Safety assessments and evaluations to determine the efficacy of JNJ-38518168 to reduce the signs and symptoms of RA will be performed at study visits. Safety will be monitored throughout the study.

Being tested
Placebo, JNJ-38518168 (3 mg), JNJ-38518168 (10 mg), JNJ-38518168 (30 mg), Methotrexate
Keywords
Rheumatoid arthritis, Swollen and tender joints, Methotrexate, Immunology, Dose range finding study
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Form=tablet, route=oral. Placebo will be administered once daily from week 0 to week 24.

  • JNJ-38518168 (3 mg)Drug

    Type=exact number, unit=mg, number=3, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

  • JNJ-38518168 (10 mg)Drug

    Type=exact number, unit=mg, number=10, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

  • JNJ-38518168 (30 mg)Drug

    Type=exact number, unit=mg, number=30, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.

  • MethotrexateDrug

    Participants must have been treated with and tolerated Methotrexate (MTX) treatment at dosages from 10 to 25 milligram per week (mg/week) inclusive, for a minimum of 6 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 through Week 24.

Study groups in NCT01679951
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Methotrexate
JNJ-38518168 (3 mg/d)ExperimentalNot described
Receives: Drug: JNJ-38518168 (3 mg); Drug: Methotrexate
JNJ-38518168 (10 mg/d)ExperimentalNot described
Receives: Drug: JNJ-38518168 (10 mg); Drug: Methotrexate
JNJ-38518168 (30 mg/d)ExperimentalNot described
Receives: Drug: JNJ-38518168 (30 mg); Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Activity Score 28 (DAS28) (C-reactive protein [CRP]) at Week 12

    The DAS28 using CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and Patient'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.

    Measured: Baseline and Week 12

Secondary outcomes (16)

  1. Change from baseline in DAS28 (CRP) at Week 24

    Measured: Baseline and Week 24

  2. Change from baseline in DAS28 (erythrocyte sedimentation rate [ESR]) at Week 12 and Week 24

    Measured: Baseline, Week 12 and Week 24

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

    Measured: Week 12 and Week 24

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

    Measured: Week 12 and Week 24

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

    Measured: Week 12 and Week 24

  6. DAS28 (ESR) remission rates at Week 12 and Week 24

    Measured: Week 12 and Week 24

  7. American College of Rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24

    An ACR 20/50/70 response is defined as a greater than or equal to 20/50/70 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).

    Measured: Week 12 and Week 24

  8. Hybrid ACR response at Week 12 and Week 24

    The hybrid ACR response is a continuous variable that is limited to an overall score of -100 (maximal worsening) to +100 (maximal improvement).

    Measured: Week 12 and Week 24

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

    According to the ACR/EULAR provisional definition, a patients RA can be defined as being in remission based on either of 2 definitions:

    when scores on the tender joint count, swollen joint count, CRP (in mg/dL), and patient global assessment (0-10 scale) are all less than or equal to 1 OR when the score on the simplified disease activity index (SDAI) is less than or equal to 3.3 Analyses based on each definition will be performed.

    Measured: Week 12 and Week 24

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

    The SDAI is the numerical sum of 5 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment of disease activity (PGA VAS in cm), physician global assessment of disease activity (MDGA VAS in cm) and C-reactive protein (CRP in mg/dL).

    Measured: Baseline, Week 12 and Week 24

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

    The CDAI is the numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA, and MDGA.

    Measured: Baseline, Week 12 and Week 24

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

    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 (no difficulty), to 3 (inability to perform a task in that area).

    Measured: Week 12 and Week 24

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

    Measured: Baseline, Week 12 and Week 24

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

    Measured: Baseline, Week 12 and Week 24

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

    Measured: Baseline, Week 12 and Week 24

  16. Number of patients with adverse events

    Measured: Up to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2012 (estimated)
  2. Study start31 Oct 2012
  3. Primary completion17 Apr 2014
  4. Study completion3 Jul 2014

Why it stopped: The decision was made to prematurely discontinue this trial due to lack of efficacy.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01679951
Sponsor's protocol ID
CR100734
Other IDs
38518168ARA2002, 2011-002840-29
Status last verified
Mar 2019
First submitted
3 Sep 2012
Last updated
18 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-38518168 (3 mg), JNJ-38518168 (10 mg) and JNJ-38518168 (30 mg) in people with Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 85 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in Japan, United States, Mexico, Russia, Poland and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The decision was made to prematurely discontinue this trial due to lack of efficacy.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Activity Score 28 (DAS28) (C-reactive protein [CRP]) at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01679951.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.

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