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Active Rheumatoid Arthritis; Rheumatoid ArthritisPhase 2NCT01480388

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

A Phase 2 study testing JNJ-39758979 (10 mg), JNJ-39758979 (30 mg) and JNJ-39758979 (100 mg) in people with Active Rheumatoid Arthritis; Rheumatoid Arthritis, run by Janssen Research & Development, LLC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
JNJ-39758979 (10 mg), JNJ-39758979 (30 mg) and JNJ-39758979 (100 mg)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2011to Mar 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 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.

Who cannot join

  • 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
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  • 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

About this study

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

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).

Read the 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.

Being tested
Placebo/JNJ-39758979 (300 mg/d), JNJ-39758979 (10 mg), JNJ-39758979 (30 mg), JNJ-39758979 (100 mg), JNJ-39758979 (300 mg)
Keywords
Rheumatoid arthritis, Swollen and tender joints, Dose range finding study, Concurrent treatment with methotrexate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Placebo/JNJ-39758979 (300 mg/d)Drug

    Also called Inactive medical substance

    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.

  • JNJ-39758979 (10 mg)Drug

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

  • JNJ-39758979 (30 mg)Drug

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

  • JNJ-39758979 (100 mg)Drug

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

  • JNJ-39758979 (300 mg)Drug

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

Study groups in NCT01480388
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo/JNJ-39758979 (300 mg/d)
JNJ-39758979 (10 mg/d)ExperimentalNot described
Receives: Drug: JNJ-39758979 (10 mg)
JNJ-39758979 (30 mg/d)ExperimentalNot described
Receives: Drug: JNJ-39758979 (30 mg)
JNJ-39758979 (100 mg/d)ExperimentalNot described
Receives: Drug: JNJ-39758979 (100 mg)
JNJ-39758979 (300 mg/d)ExperimentalNot described
Receives: Drug: JNJ-39758979 (300 mg)

What is being measured

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

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

    Measured: Baseline, Week 12

Secondary outcomes (14)

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

    Measured: Baseline, Week 24

  2. Change from baseline in DAS28 (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, Week 24

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

    Measured: Week 12, Week 24

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

    Measured: Week 12, Week 24

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

    Measured: Week 12, Week 24

  7. Hybrid ACR response at Week 12 and Week 24

    Measured: Week 12, Week 24

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

    Measured: Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Baseline, Week 12, Week 24

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

    Measured: Week 12, Week 24

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

    Measured: Baseline, Week 12 and Week 24

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

    Measured: Baseline, Week 12 and Week 24

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

    Measured: Baseline, Week 12 and Week 24

Timeline

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

  1. First posted28 Nov 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionMar 2014 (estimated)
  4. Study completionMar 2014 (estimated)

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

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01480388
Sponsor's protocol ID
CR018814
Other IDs
39758979ARA2001, 2011-002849-36
Status last verified
Nov 2016
First submitted
23 Nov 2011
Last updated
1 Dec 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-39758979 (10 mg), JNJ-39758979 (30 mg) and JNJ-39758979 (100 mg) in people with Active Rheumatoid Arthritis; Rheumatoid Arthritis, run by Janssen Research & Development, LLC.

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 6 inclusion and 12 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: withdrawn, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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?

The primary end point is change from baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12 (time frame: Baseline, 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 NCT01480388.

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 1 Dec 2016.

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