Rheumatoid ArthritisPhase 2NCT01909427
An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
A Phase 2 study testing CNTO 6785 200 mg, CNTO 6785 100 mg and CNTO 6785 50 mg in people with Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 32 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CNTO 6785 200 mg, CNTO 6785 100 mg and CNTO 6785 50 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 32 sitesin 7 countries
- Study dates
- Jun 2013to May 2015
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
Russia9 sites
Study site
Barnaul
Study site
Kemerovo
Study site
Kursk
Study site
Moscow
Study site
Novosibirsk
Study site
Petrozavodsk
Study site
Saint Petersburg
Study site
Yaroslavl
Study site
Yekaterinburg
Poland7 sites
Study site
Bydgoszcz
Study site
Grodzisk Mazowiecki
Study site
Lodz
Study site
Lublin
Study site
Poznan
Study site
Warsaw
Study site
Wroclaw
Argentina5 sites
Study site
Buenos Aires
Study site
Ciudad Autonoma Buenos Aires
Study site
Córdoba
Study site
La Capital
Study site
San Juan
Philippines4 sites
Study site
Cebu
Study site
Iloilo City
Study site
Lipa City
Study site
Quezon City
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Placebo, CNTO 6785 200 mg, CNTO 6785 100 mg, CNTO 6785 50 mg, CNTO 6785 15 mg
- Keywords
- Active rheumatoid arthritis despite methotrexate therapy, CNTO 6785, 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.
PlaceboDrug
Placebo subcutaneous injections (SC) every 4 weeks through Week 12
CNTO 6785 200 mgDrug
CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28
CNTO 6785 200 mgDrug
CNTO 6785 200 mg SC every 4 weeks through Week 28
CNTO 6785 100 mgDrug
CNTO 6785 100 mg SC every 4 weeks through Week 28
CNTO 6785 50 mgDrug
CNTO 6785 50 mg SC every 4 weeks through Week 28
CNTO 6785 15 mgDrug
CNTO 6785 15 mg SC every 4 weeks through Week 28
Methotrexate (MTX)Drug
MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
| Study group | Role | What they receive |
|---|---|---|
| Placebo/CNTO 6785 200 mg+Methotrexate (MTX) | Placebo comparator | Not described Receives: Drug: Placebo; Drug: CNTO 6785 200 mg; Drug: Methotrexate (MTX) |
| CNTO 6785 200 mg+MTX | Experimental | Not described Receives: Drug: CNTO 6785 200 mg; Drug: Methotrexate (MTX) |
| CNTO 6785 100 mg+MTX | Experimental | Not described Receives: Drug: CNTO 6785 100 mg; Drug: Methotrexate (MTX) |
| CNTO 6785 50 mg+MTX | Experimental | Not described Receives: Drug: CNTO 6785 50 mg; Drug: Methotrexate (MTX) |
| CNTO 6785 15 mg+MTX | Experimental | Not described Receives: Drug: CNTO 6785 15 mg; Drug: Methotrexate (MTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (22)
Change from baseline in DAS28 (CRP) at Week 16
DAS28 (using CRP [C-reactive protein]) is a measure of tender and swollen joints and the patient's assessment of disease activity.
Measured: Baseline to Week 16
The proportion of participants who achieve ACR 50 response at Week 16
American College of Rheumatology (ACR) 50 response is a >=50% improvement in rheumatoid arthritis (RA) symptoms.
Measured: Week 16
The proportion of participants who achieve ACR 20 response through Week 32
Measured: Week 32
The proportion of participants who achieve ACR 50 response through Week 32
Measured: Week 32
The proportion of participants who achieve ACR 70 response through Week 32
American College of Rheumatology (ACR) 70 response is a >=70% improvement in rheumatoid arthritis (RA) symptoms.
Measured: Week 32
Change from baseline of DAS28 (CRP) through Week 32
Measured: Baseline to Week 32
The proportion of participants with DAS28 (CRP) response through Week 32
DAS28 (using CRP [C-reactive protein]) response is improvement from baseline, with >1.2 indicating a good or moderate response and <=0.6 indicating no response.
Measured: Week 32
The proportion of participants with DAS28 (CRP) remission at Week 16
DAS28 (using CRP [C-reactive protein]) remission is defined as a value of <2.6 on the Disease Activity Index, a measure of tender and swollen joints and the patient's assessment of disease activity.
Measured: Week 16
The proportion of participants with DAS28 (CRP) remission at Week 32
Measured: Week 32
Change from baseline in DAS28 (ESR) at Week 16
DAS28 (using erythrocyte sedimentation rate) is a measure of tender and swollen joints and the patient's assessment of disease activity.
Measured: Baseline to Week 16
Change from baseline in DAS28 (ESR) at Week 32
Measured: Baseline to Week 32
Change from baseline in HAQ-DI score through Week 32
The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas, each scored from 0 (no difficulty) to 3 (inability to perform a task).
Measured: Baseline to Week 32
Change from baseline in SF-36 at Week 16
The SF-36 is a medical outcome study health measure and consists of 8 multi-item scales that are scored from 0 to 100, with higher scores indicating better health.
Measured: Baseline to Week 16
Change from baseline in SF-36 at Week 32
Measured: Baseline to Week 32
Change from baseline in CDAI at Week 16
Clinical Disease Activity Index (CDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, and Physician's Global Assessments of Disease Activity.
Measured: Baseline to Week 16
Change from baseline in CDAI at Week 32
Measured: Baseline to Week 32
Change from baseline in SDAI at Week 16
The Simplified Disease Activity Index (SDAI) score is a derived score combining tender joints (28 joints), swollen joints (28 joints), Patient's Global Assessment of Disease Activity, Physician's Global Assessments of Disease Activity, and CRP.
Measured: Baseline to Week 16
Change from baseline in SDAI at Week 32
Measured: Baseline to Week 32
The proportion of participants with SDAI-based ACR/EULAR remission at Week 16
The Simplified Disease Activity Index (SDAI)-based ACR/EULAR (European League Against Rheumatism) remission is defined as a SDAI value of <=3.3 at a visit.
Measured: Week 16
The proportion of participants with SDAI-based ACR/EULAR remission at Week 32
Measured: Week 32
The proportion of participants with Boolean-based ACR/EULAR remission at Week 16
Boolean-based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 mg/dL; and Patient's Global Assessment of Disease Activity on VAS <=1 on a 0 to 10 scale.
Measured: Week 16
The proportion of participants with Boolean-based ACR/EULAR remission at Week 32
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909427
- Sponsor's protocol ID
- CR100935
- Other IDs
- CNTO6785ARA2001, 2012-003629-40
- Status last verified
- Feb 2016
- First submitted
- 10 Jul 2013
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01909427
- Acronym / sponsor ID
- CR100935
- Conditions
- Rheumatoid Arthritis
- Keywords
- Active rheumatoid arthritis despite methotrexate therapy, CNTO 6785, Methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo subcutaneous injections (SC) every 4 weeks through Week 12 | Drug | Placebo/CNTO 6785 200 mg+Methotrexate (MTX) |
| CNTO 6785 200 mgCNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28 | Drug | Placebo/CNTO 6785 200 mg+Methotrexate (MTX) |
| CNTO 6785 200 mgCNTO 6785 200 mg SC every 4 weeks through Week 28 | Drug | CNTO 6785 200 mg+MTX |
| CNTO 6785 100 mgCNTO 6785 100 mg SC every 4 weeks through Week 28 | Drug | CNTO 6785 100 mg+MTX |
| CNTO 6785 50 mgCNTO 6785 50 mg SC every 4 weeks through Week 28 | Drug | CNTO 6785 50 mg+MTX |
| CNTO 6785 15 mgCNTO 6785 15 mg SC every 4 weeks through Week 28 | Drug | CNTO 6785 15 mg+MTX |
| Methotrexate (MTX)MTX at the same stable dose through Week 32, that participants were receiving prior to screening. | Drug | 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) |
Primary outcome
The proportion of participants who achieve an ACR 20 response at Week 16
Time frame: Week 16
American College of Rheumatology (ACR) 20 response is a >=20% improvement in rheumatoid arthritis (RA) symptoms.
22 secondary outcomes
Change from baseline in DAS28 (CRP) at Week 16
Time frame: Baseline to Week 16
The proportion of participants who achieve ACR 50 response at Week 16
Time frame: Week 16
The proportion of participants who achieve ACR 20 response through Week 32
Time frame: Week 32
The proportion of participants who achieve ACR 50 response through Week 32
Time frame: Week 32
The proportion of participants who achieve ACR 70 response through Week 32
Time frame: Week 32
Change from baseline of DAS28 (CRP) through Week 32
Time frame: Baseline to Week 32
The proportion of participants with DAS28 (CRP) response through Week 32
Time frame: Week 32
The proportion of participants with DAS28 (CRP) remission at Week 16
Time frame: Week 16
The proportion of participants with DAS28 (CRP) remission at Week 32
Time frame: Week 32
Change from baseline in DAS28 (ESR) at Week 16
Time frame: Baseline to Week 16
Change from baseline in DAS28 (ESR) at Week 32
Time frame: Baseline to Week 32
Change from baseline in HAQ-DI score through Week 32
Time frame: Baseline to Week 32
Change from baseline in SF-36 at Week 16
Time frame: Baseline to Week 16
Change from baseline in SF-36 at Week 32
Time frame: Baseline to Week 32
Change from baseline in CDAI at Week 16
Time frame: Baseline to Week 16
Change from baseline in CDAI at Week 32
Time frame: Baseline to Week 32
Change from baseline in SDAI at Week 16
Time frame: Baseline to Week 16
Change from baseline in SDAI at Week 32
Time frame: Baseline to Week 32
The proportion of participants with SDAI-based ACR/EULAR remission at Week 16
Time frame: Week 16
The proportion of participants with SDAI-based ACR/EULAR remission at Week 32
Time frame: Week 32
The proportion of participants with Boolean-based ACR/EULAR remission at Week 16
Time frame: Week 16
The proportion of participants with Boolean-based ACR/EULAR remission at Week 32
Time frame: Week 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNTO 6785 200 mg, CNTO 6785 100 mg and CNTO 6785 50 mg in people with Rheumatoid Arthritis, run by Janssen Research & Development, LLC at 32 sites in 7 countries.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Russia, Poland, Argentina, Philippines, Colombia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 proportion of participants who achieve an ACR 20 response at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2016.