Clinical trial NCT01909427: An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Official title: A Randomized, Placebo-controlled Double-blind, Multicenter, Phase 2 Dose Ranging Study To Assess The Efficacy And Safety of CNTO 6785 In Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Active rheumatoid arthritis despite methotrexate therapy
CNTO 6785
Methotrexate
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2013-07-26
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.

Detailed description: This is a randomized (participants are assigned to treatment by chance), double-blind (participants and study personnel will not know which treatments are being given), placebo-controlled (a placebo appears identical to a study drug but has no active ingredients), multicenter study. The study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. Approximately 250 participants with active RA despite MTX therapy will be randomly assigned to receive placebo or CNTO 6785 during the double-blind treatment phase. The maximum period of active treatment will be 28 weeks. The maximum duration of study participation will be 44 weeks. Participant safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening
* Have active RA defined study as persistent disease activity with both of the following criteria: 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 (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline
* Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent

Exclusion Criteria:

* Has inflammatory diseases other than RA, that might confound the evaluation of the benefit of study agent therapy
* Has a diagnosis of fibromyalgia
* Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant
* At screening, the results of laboratory tests must meet protocol-specified criteria
* Has ever received any approved or investigational biologic agent for a rheumatic indication

Primary outcomes:
measure: The proportion of participants who achieve an ACR 20 response at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Change from baseline in DAS28 (CRP) at Week 16
timeFrame: Baseline to Week 16
measure: The proportion of participants who achieve ACR 50 response at Week 16
timeFrame: Week 16
measure: The proportion of participants who achieve ACR 20 response through Week 32
timeFrame: Week 32
measure: The proportion of participants who achieve ACR 50 response through Week 32
timeFrame: Week 32
measure: The proportion of participants who achieve ACR 70 response through Week 32
timeFrame: Week 32
measure: Change from baseline of DAS28 (CRP) through Week 32
timeFrame: Baseline to Week 32
measure: The proportion of participants with DAS28 (CRP) response through Week 32
timeFrame: Week 32
measure: The proportion of participants with DAS28 (CRP) remission at Week 16
timeFrame: Week 16
measure: The proportion of participants with DAS28 (CRP) remission at Week 32
timeFrame: Week 32
measure: Change from baseline in DAS28 (ESR) at Week 16
timeFrame: Baseline to Week 16
measure: Change from baseline in DAS28 (ESR) at Week 32
timeFrame: Baseline to Week 32
measure: Change from baseline in HAQ-DI score through Week 32
timeFrame: Baseline to Week 32
measure: Change from baseline in SF-36 at Week 16
timeFrame: Baseline to Week 16
measure: Change from baseline in SF-36 at Week 32
timeFrame: Baseline to Week 32
measure: Change from baseline in CDAI at Week 16
timeFrame: Baseline to Week 16
measure: Change from baseline in CDAI at Week 32
timeFrame: Baseline to Week 32
measure: Change from baseline in SDAI at Week 16
timeFrame: Baseline to Week 16
measure: Change from baseline in SDAI at Week 32
timeFrame: Baseline to Week 32
measure: The proportion of participants with SDAI-based ACR/EULAR remission at Week 16
timeFrame: Week 16
measure: The proportion of participants with SDAI-based ACR/EULAR remission at Week 32
timeFrame: Week 32
measure: The proportion of participants with Boolean-based ACR/EULAR remission at Week 16
timeFrame: Week 16
measure: The proportion of participants with Boolean-based ACR/EULAR remission at Week 32
timeFrame: Week 32
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: La Capital
country: Argentina
city: San Juan
country: Argentina
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Medellín
country: Colombia
city: Jihlava
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Praha
country: Czech Republic
city: Cebu
country: Philippines
city: Iloilo City
country: Philippines
city: Lipa City
country: Philippines
city: Quezon City
country: Philippines
city: Bydgoszcz
country: Poland
city: Grodzisk Mazowiecki
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Barnaul
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: