Rheumatoid ArthritisPhase 2NCT00941707
An Efficacy and Safety Study of JNJ-38518168 in Adult Participants With Rheumatoid Arthritis
A Phase 2 study testing JNJ 38518168 in people with Rheumatoid Arthritis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 34 sites in 10 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis (long time systemic disease of the joints, marked by inflammatory changes in the synovial membranes and bones) despite methotrexate (MTX) therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- JNJ 38518168
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 34 sitesin 10 countries
- Study dates
- Feb 2010to Nov 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with rheumatoid arthritis (RA) according to the revised 1987 criteria of the ARA (Arnett et al, 1988) for at least 6 months at Screening
- Participants who have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 milligram (mg) per week inclusive, for a minimum of 4 months before Screening
- Participants if using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics (drug used to control pain) regularly for RA, participants must have been on a stable dose for at least 2 weeks before the first dose of study medication
- Participants if using oral corticosteroids (compounds, usually hormonal, taken orally [by mouth] in order to block ovulation [discharge of an egg from the ovary] and prevent the occurrence of pregnancy [carrying an unborn baby]), must be on a stable dose of less than or equal to 10 mg per day of prednisone or another oral corticosteroid for at least 4 weeks before the first dose of study medication and continue with the same dose throughout the study. If not using corticosteroids at study initiation, the participant must have not received any oral corticosteroids for at least 4 weeks before the first dose of study medication
- Participants currently treated with folic acid at a minimum dose of 5 mg per week
Who cannot join
- Participants having inflammatory disease other than RA
- Participant who have used any of the following medications: D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold salts, sulfasalazine, leflunomide, azathioprine, cyclosporine, tacrolimus, and mycophenolatemofetil
- Participant who have received intra-articular, intramuscular (into the muscle), or intravenous (into the vein) corticosteroids, including adrenocorticotropic hormone (hormone made by the brain that activates the adrenal glands) within 4 weeks before the first dose of the study medication
- Participants who have been treated with any other investigational drug or medical device within 4 weeks or 5 half-lives of the drug, whichever is longer before the first dose of study medication
- Participants who have undergone surgical treatments for RA including synoviectomy (surgical removal of a part of the synovial membrane of a joint) and arthroplasty (surgery to fix a joint) within 3 months before the first dose of study medication
Trial locations and contacts
34 sites in 10 countries.
34 sites in 10 countries
Russia7 sites
Study site
Kemerovo
Study site
Moscow
Study site
Novosibirsk
Study site
Petrozavodsk
Study site
Saint Petersburg
Study site
Yaroslavl
Study site
Yekaterinburg
Czechia5 sites
Study site
Brno
Study site
Kladno
Study site
Prague
Study site
Uherské Hradiště
Study site
Zlín
Poland5 sites
Study site
Bialystok
Study site
Bydgoszcz
Study site
Elblag
Study site
Lublin
Study site
Torun
Spain4 sites
Study site
Barcelona
Study site
Guadalajara
Study site
Santiago de Compostela
Study site
Seville
United Kingdom4 sites
Study site
London
Study site
Middlesbrough
Study site
Salford
Study site
Wigan
About this study
Official title: A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy
The purpose of this study is to evaluate the efficacy, tolerability and safety of JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis (long time systemic disease of the joints, marked by inflammatory changes in the synovial membranes and bones) despite methotrexate (MTX) therapy.
Read the detailed description
This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) and parallel-group (each group of participants will be treated at the same time) study. The study will consist of 3 phases; Screening phase (3 weeks), Treatment phase (12 weeks) and Follow-up phase (4 weeks). Each participant will be enrolled in the study for approximately 19 weeks. Participants with active rheumatoid arthritis despite MTX therapy will receive JNJ-38518168, 100 milligram (mg) per day or matching placebo capsules once daily for 12 weeks. Efficacy will be primarily evaluated by change from Baseline in disease activity index score C-reactive protein at Week 12. Participants' safety will be monitored throughout the study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- JNJ 38518168, Placebo
- Keywords
- Rheumatoid Arthritis, JNJ-38518168
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ 38518168Drug
JNJ-38518168 100 milligram (mg) capsules orally (by mouth) once daily for 12 weeks.
PlaceboDrug
Placebo capsules matching to JNJ-38518168 orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-38518168 | Experimental | Not described Receives: Drug: JNJ 38518168 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Disease Activity Index Score (DAS28) C-Reactive Protein (CRP) at Week 12
The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.
Measured: Baseline and Week 12
Secondary outcomes (10)
Percentage of Participants With DAS28 (CRP) Response
The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, MCP1 to MCP5, proximal PIP, PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.
Measured: Week 12
Percentage of Participants With DAS28 (ESR) Response
The DAS28 based on erythrocyte sedimentation rate (ESR) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR and global health (GH). The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).
Measured: Week 12
Change From Baseline in DAS28 (ESR) Score at Week 12
The DAS28 based on ESR is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), ESR, and GH. The DAS28-ESR is expressed on a score on a scale with the minimum score=0 (best) to maximum score=10 (worst).
Measured: Baseline and Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR20) Response
The ACR20 response is defined as more than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter (mm), 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP.
Measured: Week 12
Percentage of Participants Achieving ACR50 Response
The ACR50 response is defined as >=0 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of the following 5 assessments: participant's assessment of pain using VAS, participant's global assessment of disease activity by using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function as measured by HAQ-DI and CRP.
Measured: Week 12
ACR-N Index Score
The ACR-N Index of improvement is defined as the minimum of the following 3 criteria: percent improvement from Baseline in tender joint counts, percent improvement from Baseline in swollen joint counts and median percent improvement from Baseline for the following 5 assessments: participant's assessment of pain using VAS, participant's global assessment of disease activity using VAS, physician's global assessment of disease activity using VAS, participant's assessment of physical function as measured by HAQ-DI and CRP. Negative numbers indicate worsening.
Measured: Week 12
Change From Baseline in HAQ-DI at Week 12
The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area).
Measured: Baseline and Week 12
Change From Baseline in Participant's Assessment of Pain at Week 12
Participants will assess their average pain on a VAS. The scale ranges from 0 mm to 100 mm, (0 mm=no pain to 100 mm=worst possible pain).
Measured: Baseline and Week 12
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
The Investigator's global disease assessments will be recorded on a VAS. The scale for the Investigator's assessments ranges from 0 mm to 100 mm (0 mm=no arthritis activity, 100 mm=extremely active arthritis).
Measured: Baseline and Week 12
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12
The participant's global disease assessments will be recorded on a VAS. The scale ranges from 0 mm to 100 mm (0 mm=very well to 100 mm=very poor).
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Due to a single, unexpected serious event, the trial was stopped.
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941707
- Sponsor's protocol ID
- CR016414
- Other IDs
- 2009-012118-27, 38518168ARA2001, 2009
- Status last verified
- Apr 2013
- First submitted
- 16 Jul 2009
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy
- ClinicalTrials.gov ID
- NCT00941707
- Acronym / sponsor ID
- CR016414
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, JNJ-38518168
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a single, unexpected serious event, the trial was stopped.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 20 Jul 2009 (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 evaluate the efficacy, tolerability and safety of JNJ-38518168 compared with placebo in adult participants with active rheumatoid arthritis (long time systemic disease of the joints, marked by inflammatory changes in the synovial membranes and bones) despite methotrexate (MTX) therapy.
Detailed description
This is a multi-center (when more than 1 hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) and parallel-group (each group of participants will be treated at the same time) study. The study will consist of 3 phases; Screening phase (3 weeks), Treatment phase (12 weeks) and Follow-up phase (4 weeks). Each participant will be enrolled in the study for approximately 19 weeks. Participants with active rheumatoid arthritis despite MTX therapy will receive JNJ-38518168, 100 milligram (mg) per day or matching placebo capsules once daily for 12 weeks. Efficacy will be primarily evaluated by change from Baseline in disease activity index score C-reactive protein at Week 12. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-38518168 | Experimental | Drug: JNJ 38518168 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants diagnosed with rheumatoid arthritis (RA) according to the revised 1987 criteria of the ARA (Arnett et al, 1988) for at least 6 months at Screening
- Participants who have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 milligram (mg) per week inclusive, for a minimum of 4 months before Screening
- Participants if using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics (drug used to control pain) regularly for RA, participants must have been on a stable dose for at least 2 weeks before the first dose of study medication
- Participants if using oral corticosteroids (compounds, usually hormonal, taken orally [by mouth] in order to block ovulation [discharge of an egg from the ovary] and prevent the occurrence of pregnancy [carrying an unborn baby]), must be on a stable dose of less than or equal to 10 mg per day of prednisone or another oral corticosteroid for at least 4 weeks before the first dose of study medication and continue with the same dose throughout the study. If not using corticosteroids at study initiation, the participant must have not received any oral corticosteroids for at least 4 weeks before the first dose of study medication
- Participants currently treated with folic acid at a minimum dose of 5 mg per week
Key exclusion criteria (5 listed)
- Participants having inflammatory disease other than RA
- Participant who have used any of the following medications: D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold salts, sulfasalazine, leflunomide, azathioprine, cyclosporine, tacrolimus, and mycophenolatemofetil
- Participant who have received intra-articular, intramuscular (into the muscle), or intravenous (into the vein) corticosteroids, including adrenocorticotropic hormone (hormone made by the brain that activates the adrenal glands) within 4 weeks before the first dose of the study medication
- Participants who have been treated with any other investigational drug or medical device within 4 weeks or 5 half-lives of the drug, whichever is longer before the first dose of study medication
- Participants who have undergone surgical treatments for RA including synoviectomy (surgical removal of a part of the synovial membrane of a joint) and arthroplasty (surgery to fix a joint) within 3 months before the first dose of study medication
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 |
|---|---|---|
| JNJ 38518168JNJ-38518168 100 milligram (mg) capsules orally (by mouth) once daily for 12 weeks. | Drug | JNJ-38518168 |
| PlaceboPlacebo capsules matching to JNJ-38518168 orally once daily for 12 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Disease Activity Index Score (DAS28) C-Reactive Protein (CRP) at Week 12
Time frame: Baseline and Week 12
The DAS28 based on CRP is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and participant's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.
10 secondary outcomes
Percentage of Participants With DAS28 (CRP) Response
Time frame: Week 12
Percentage of Participants With DAS28 (ESR) Response
Time frame: Week 12
Change From Baseline in DAS28 (ESR) Score at Week 12
Time frame: Baseline and Week 12
Percentage of Participants Achieving American College of Rheumatology (ACR20) Response
Time frame: Week 12
Percentage of Participants Achieving ACR50 Response
Time frame: Week 12
ACR-N Index Score
Time frame: Week 12
Change From Baseline in HAQ-DI at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Participant's Assessment of Pain at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12
Time frame: Baseline and Week 12
Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12
Time frame: Baseline and Week 12
Results and safety
The study was stopped early (reason given: Due to a single, unexpected serious event, the trial was stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
34 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ 38518168 in people with Rheumatoid Arthritis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 34 sites in 10 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 5 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: stopped early, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Russia, Czechia, Poland, Spain, United Kingdom and 5 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 was stopped early (reason given: Due to a single, unexpected serious event, the trial was stopped.). Results are not available in the source record.
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?
Change From Baseline in Disease Activity Index Score (DAS28) C-Reactive Protein (CRP) at Week 12 (time frame: Baseline and Week 12). 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 23 Apr 2013.