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

This study has been terminated.
(Study was terminated prematurely due to 2 cases of agranulocytosis in a different clinical trial with this same drug.)
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01480388
First received: November 23, 2011
Last updated: August 16, 2013
Last verified: August 2013

November 23, 2011
August 16, 2013
November 2011
Not Provided
The primary end point is change from baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01480388 on ClinicalTrials.gov Archive Site
  • Change from baseline in DAS28 (CRP) at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in DAS28 (ESR) at Week 12 and Week 24 [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • DAS28 (CRP) response rates at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • DAS28 (ESR) response rates at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • DAS28 (CRP) remission rates at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • American college of rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Hybrid ACR response at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24 [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24 [ Time Frame: Baseline, Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI) response at Week 12 and Week 24 [ Time Frame: Week 12, Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in HAQ-DI score at Week 12 and Week 24 [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • Percent change from baseline in ESR levels at Week 12 and Week 24 [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
  • Percent change from baseline in ACR components at Week 12 and Week 24 [ Time Frame: Baseline, Week 12 and Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Dose Range Finding Study of JNJ-39758979 in Patients With Active Rheumatoid Arthritis Currently Treated With Methotrexate
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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Active Rheumatoid Arthritis; Rheumatoid Arthritis
  • Drug: Placebo/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.
    Other Name: Inactive medical substance
  • Drug: JNJ-39758979 (10 mg)
    Form = tablet, route = oral adminstration once daily up to 48 weeks
  • Drug: JNJ-39758979 (30 mg)
    Form = tablet, route = oral adminstration once daily up to 48 weeks
  • Drug: JNJ-39758979 (100 mg)
    Form = tablet, route = oral adminstration once daily up to 48 weeks
  • Drug: JNJ-39758979 (300 mg)
    Form = tablet, route = oral adminstration once daily for 48 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo/JNJ-39758979 (300 mg/d)
  • Experimental: JNJ-39758979 (10 mg/d)
    Intervention: Drug: JNJ-39758979 (10 mg)
  • Experimental: JNJ-39758979 (30 mg/d)
    Intervention: Drug: JNJ-39758979 (30 mg)
  • Experimental: JNJ-39758979 (100 mg/d)
    Intervention: Drug: JNJ-39758979 (100 mg)
  • Experimental: JNJ-39758979 (300 mg/d)
    Intervention: Drug: JNJ-39758979 (300 mg)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
325
March 2014
Not Provided

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:

  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01480388
CR018814, 39758979ARA2001, 2011-002849-36
Yes
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Development, L.L.C. Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP