An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy

NCT01909427 | Completed Phase 2 DMC

• 3 other identifiers: CR100935CNTO6785ARA20012012-003629-40
• Study Type: interventional
• Target: 257
• Locations: 7 countries
• Sites: 32

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.

Conditions

Rheumatoid Arthritis

Keywords

Active rheumatoid arthritis despite methotrexate therapy; CNTO 6785; Methotrexate

Outcome Measures

Primary Outcomes (1)

• The proportion of participants who achieve an ACR 20 response at Week 16

  American College of Rheumatology (ACR) 20 response is a \>=20% improvement in rheumatoid arthritis (RA) symptoms.

  Week 16

Secondary Outcomes (22)

• Change from baseline in DAS28 (CRP) at Week 16

  Baseline to Week 16

• The proportion of participants who achieve ACR 50 response at Week 16

  Week 16

• The proportion of participants who achieve ACR 20 response through Week 32

  Week 32

• The proportion of participants who achieve ACR 50 response through Week 32

  Week 32

• The proportion of participants who achieve ACR 70 response through Week 32

  Week 32

Study Arms (5)

Placebo/CNTO 6785 200 mg+Methotrexate (MTX)

PLACEBO COMPARATOR

Drug: Placebo; Drug: CNTO 6785 200 mg; Drug: Methotrexate (MTX)

CNTO 6785 200 mg+MTX

EXPERIMENTAL

Drug: CNTO 6785 200 mg; Drug: Methotrexate (MTX)

CNTO 6785 100 mg+MTX

EXPERIMENTAL

Drug: CNTO 6785 100 mg; Drug: Methotrexate (MTX)

CNTO 6785 50 mg+MTX

EXPERIMENTAL

Drug: CNTO 6785 50 mg; Drug: Methotrexate (MTX)

CNTO 6785 15 mg+MTX

EXPERIMENTAL

Drug: CNTO 6785 15 mg; Drug: Methotrexate (MTX)

Interventions

Placebo DRUG

Placebo subcutaneous injections (SC) every 4 weeks through Week 12

Placebo/CNTO 6785 200 mg+Methotrexate (MTX)

CNTO 6785 200 mg DRUG

CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28

Placebo/CNTO 6785 200 mg+Methotrexate (MTX)

CNTO 6785 100 mg DRUG

CNTO 6785 100 mg SC every 4 weeks through Week 28

CNTO 6785 100 mg+MTX

CNTO 6785 50 mg DRUG

CNTO 6785 50 mg SC every 4 weeks through Week 28

CNTO 6785 50 mg+MTX

CNTO 6785 15 mg DRUG

CNTO 6785 15 mg SC every 4 weeks through Week 28

CNTO 6785 15 mg+MTX

Methotrexate (MTX) DRUG

MTX at the same stable dose through Week 32, that participants were receiving prior to screening.

CNTO 6785 100 mg+MTX; CNTO 6785 15 mg+MTX; CNTO 6785 200 mg+MTX; CNTO 6785 50 mg+MTX; Placebo/CNTO 6785 200 mg+Methotrexate (MTX)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (32)

Unknown Facility

Buenos Aires, Argentina

Location

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Ciudad Autonoma Buenos Aires, Argentina

Location

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Córdoba, Argentina

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La Capital, Argentina

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San Juan, Argentina

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Barranquilla, Colombia

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Bogotá, Colombia

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Medellín, Colombia

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Jihlava, Czechia

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Prague, Czechia

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Cebu, Philippines

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Iloilo City, Philippines

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Lipa City, Philippines

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Quezon City, Philippines

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Bydgoszcz, Poland

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Grodzisk Mazowiecki, Poland

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Lodz, Poland

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Lublin, Poland

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Poznan, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Barnaul, Russia

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Kemerovo, Russia

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Kursk, Russia

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Moscow, Russia

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Novosibirsk, Russia

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Petrozavodsk, Russia

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Saint Petersburg, Russia

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Yaroslavl, Russia

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Yekaterinburg, Russia

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Bangkok, Thailand

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Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 26, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: March 2, 2016

Record last verified: 2016-02

Locations

CO (3); AR (5); CZ (2); PL (7); TH (2); PH (4); RU (9)