CClinicalTrials.gg
Sign In
WithdrawnNCT01480388Updated Dec 1, 2016

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

A Phase 2 interventional study of Placebo/JNJ-39758979 (300 mg/d) and JNJ-39758979 (10 mg) in Active Rheumatoid Arthritis; Rheumatoid Arthritis, sponsored by Janssen Research & Development, LLC. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-01.

Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Study was terminated prematurely due to 2 cases of agranulocytosis in a different clinical trial with this same drug.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Active Rheumatoid Arthritis; Rheumatoid Arthritis

Keywords

  • Rheumatoid arthritis
  • Swollen and tender joints
  • Dose range finding study
  • Concurrent treatment with methotrexate
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

Browse Arthritis studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Placebo

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

  • Experimental
    JNJ-39758979 (10 mg/d)

    Drug: JNJ-39758979 (10 mg)

  • Experimental
    JNJ-39758979 (30 mg/d)

    Drug: JNJ-39758979 (30 mg)

  • Experimental
    JNJ-39758979 (100 mg/d)

    Drug: JNJ-39758979 (100 mg)

  • Experimental
    JNJ-39758979 (300 mg/d)

    Drug: JNJ-39758979 (300 mg)

Interventions

  • DrugPlacebo/JNJ-39758979 (300 mg/d)

    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.

    Also known as: Inactive medical substance

  • DrugJNJ-39758979 (10 mg)

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

  • DrugJNJ-39758979 (30 mg)

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

  • DrugJNJ-39758979 (100 mg)

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

  • DrugJNJ-39758979 (300 mg)

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

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Week 12

Secondary outcomes

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

    Time frame: Baseline, Week 24

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

    Time frame: Baseline, Week 12 and Week 24

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

    Time frame: Week 12, Week 24

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

    Time frame: Week 12, Week 24

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

    Time frame: Week 12, Week 24

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

    Time frame: Week 12, Week 24

  7. Hybrid ACR response at Week 12 and Week 24

    Time frame: Week 12, Week 24

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

    Time frame: Week 12, Week 24

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

    Time frame: Baseline, Week 12, Week 24

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

    Time frame: Baseline, Week 12, Week 24

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

    Time frame: Week 12, Week 24

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

    Time frame: Baseline, Week 12 and Week 24

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

    Time frame: Baseline, Week 12 and Week 24

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

    Time frame: Baseline, Week 12 and Week 24

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01480388
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Nov 28, 2011
Start date
Dec 2011
Primary completion
Mar 2014 (estimated)
Completion
Mar 2014 (estimated)
Last update
Dec 1, 2016

Study contacts

Janssen Research & Development, LLC Development, L.L.C. Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arthritis→

Other studies from this sponsor

Janssen Research & Development, LLC

Start the discussion