A Phase 3 interventional study of Placebo and Golimumab in Arthritis, Psoriatic, sponsored by Janssen Research & Development, LLC. Completed at 89 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-21.
Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).
This is a Phase 3, multicenter (when more than one hospital or medical school team work on a medical research study), randomized (study drug assigned by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), 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) study of golimumab compared with placebo in participants with active psoriatic arthritis. The study will include 4 phases: Screening phase (up to 6 weeks), Double-blind placebo-controlled phase (Week 0 to Week 24), Active treatment phase (Week 24 to Week 52), and Safety follow-up phase (8 weeks from last study drug administration). Total duration of the study will be 60 weeks per participant. Eligible Participants will be randomly assigned to either Treatment Group 1: Placebo or Treatment Group 2: Golimumab. Participants randomized to Placebo Group, will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab (2 mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52. Participants randomized to Golimumab Group, will receive intravenous infusions of golimumab 2 mg/kg at Week 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants randomized to golimumab Group will receive a placebo infusion to maintain the blind. The efficacy will be assessed primarily by measuring percentage of participants who achieve a 20 percent improvement from baseline in the assessment used in active psoriatic arthritis at Week 14. Participants' safety will be monitored throughout the study.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 480 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
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Exclusion Criteria:
Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20. At Week 24, all participants receiving placebo will begin receiving intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and thereafter every 8 weeks up to Week 52.
Drug: Placebo · Drug: Golimumab
Participants will receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52. At Week 24, participants will receive a placebo infusion to maintain the blind.
Drug: Placebo · Drug: Golimumab
Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.
Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14
The ACR 20 response is defined as greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Time frame: Week 14
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
The Health Assessment Questionnaire-Disability Index (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). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline and Week 14
Percentage of Participants Who Achieved an ACR 50 Response at Week 14
The ACR 50 response is defined as: greater than or equal to (\>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Time frame: Week 14
Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
Time frame: Week 14
Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.
Time frame: Baseline and Week 24
Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline
Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
Time frame: Baseline and Week 14
Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline
Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
Time frame: Baseline and Week 14
Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14
The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.
Time frame: Baseline and Week 14
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
The ACR 50 response is defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Time frame: Week 24
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14
The ACR 70 response is defined as greater than or equal to (\>=) 70 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=70% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
Time frame: Week 14
Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14
The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.
Time frame: Baseline and Week 14
| Milestone | Placebo (Week 0-24) | Placebo Then Golimumab 2 mg/kg (Week 24-60) | Golimumab 2 mg/kg (Week 0-60) |
|---|---|---|---|
| Started | 239 | 0 | 241 |
| Treated | 239 | 0 | 240 |
| Completed | 222 | 0 | 230 |
| Not completed | 17 | 0 | 11 |
| Withdrew: Adverse event | 2 | 0 | 3 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 3 |
| Withdrew: Withdrawal by subject | 10 | 0 | 1 |
| Withdrew: Other | 2 | 0 | 3 |
| Withdrew: Randomized not treated | 0 | 0 | 1 |
| Milestone | Placebo (Week 0-24) | Placebo Then Golimumab 2 mg/kg (Week 24-60) | Golimumab 2 mg/kg (Week 0-60) |
|---|---|---|---|
| Started | 0 | 222 | 230 |
| Treated | 0 | 220 | 230 |
| Completed | 0 | 214 | 213 |
| Not completed | 0 | 8 | 17 |
| Withdrew: Adverse event | 0 | 4 | 10 |
| Withdrew: Other | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 | 2 |
| Withdrew: Pregnancy | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 1 |
The ACR 20 response is defined as greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
| Percentage of Participants | Placebo | Golimumab |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 | 21.8 | 75.1 |
The Health Assessment Questionnaire-Disability Index (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). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
| units on a scale | Placebo | Golimumab |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14 | -0.12 ± 0.466 | -0.60 ± 0.530 |
The ACR 50 response is defined as: greater than or equal to (\>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
| Percentage of Participants | Placebo | Golimumab |
|---|---|---|
| Percentage of Participants Who Achieved an ACR 50 Response at Week 14 | 6.3 | 43.6 |
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
| Percentage of participants | Placebo | Golimumab |
|---|---|---|
| Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14 | 13.6 | 59.2 |
The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.
| units on a scale | Placebo | Golimumab |
|---|---|---|
| Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24 | 1.95 ± 0.264 | -0.36 ± 0.144 |
Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).
| units on a scale | Placebo | Golimumab |
|---|---|---|
| Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline | -0.8 ± 1.98 | -1.8 ± 1.75 |
Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.
| units on a scale | Placebo | Golimumab |
|---|---|---|
| Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline | -2.8 ± 7.03 | -7.8 ± 8.57 |
The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.
| units on a scale | Placebo | Golimumab |
|---|---|---|
| Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14 | 2.69 ± 5.920 | 8.65 ± 7.602 |
The ACR 50 response is defined as greater than or equal to (\>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
| Percentage of participants | Placebo | Golimumab |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24 | 6.3 | 53.5 |
The ACR 70 response is defined as greater than or equal to (\>=) 70 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and \>=70% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter \[cm\] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).
| Percentage of participants | Placebo | Golimumab |
|---|---|---|
| Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14 | 2.1 | 24.5 |
The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.
| units on a scale | Placebo | Golimumab |
|---|---|---|
| Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14 | 0.97 ± 7.644 | 5.33 ± 9.948 |
Collected over Up to 60 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo (Week 0-24) | — | 8/239 (3.3%) | 19/239 (7.9%) |
| Placebo Then Golimumab 2 mg/kg (Week 24-60) | — | 5/220 (2.3%) | 25/220 (11.4%) |
| Golimumab 2 mg/kg (Week 0-60) | — | 19/240 (7.9%) | 40/240 (16.7%) |
| Event | Placebo (Week 0-24) | Placebo Then Golimumab 2 mg/kg (Week 24-60) | Golimumab 2 mg/kg (Week 0-60) |
|---|---|---|---|
| PneumoniaInfections and infestations | 1/239 | 1/220 | 2/240 |
| Pulmonary tuberculosisInfections and infestations | 0/239 | 0/220 | 2/240 |
| EmpyemaInfections and infestations | 0/239 | 1/220 | 0/240 |
| PeriodontitisInfections and infestations | 0/239 | 1/220 | 0/240 |
| Urinary tract infectionInfections and infestations | 0/239 | 1/220 | 0/240 |
| Gene mutation identification test positiveInvestigations | 0/239 | 1/220 | 0/240 |
| Laboratory test abnormalInvestigations | 0/239 | 1/220 | 0/240 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/239 | 1/220 | 0/240 |
| Cardiac failure acuteCardiac disorders | 1/239 | 0/220 | 0/240 |
| CataractEye disorders | 1/239 | 0/220 | 0/240 |
| Event | Placebo (Week 0-24) | Placebo Then Golimumab 2 mg/kg (Week 24-60) | Golimumab 2 mg/kg (Week 0-60) |
|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 5/239 | 13/220 | 25/240 |
| Aspartate aminotransferase increasedInvestigations | 5/239 | 12/220 | 19/240 |
| NasopharyngitisInfections and infestations | 13/239 | 9/220 | 14/240 |
| Age, Categorical(Participants) | Placebo (Week 0-24) | Golimumab 2 mg/kg | Total |
|---|---|---|---|
| <=18 years | 2 | 0 | 2 |
| Between 18 and 65 years | 216 | 228 | 444 |
| >=65 years | 21 | 13 | 34 |
| Age, Continuous(years) | Placebo (Week 0-24) | Golimumab 2 mg/kg | Total |
|---|---|---|---|
| Mean | 46.7 ± 12.53 | 45.7 ± 11.25 | 46.2 ± 11.9 |
| Sex: Female, Male(Participants) | Placebo (Week 0-24) | Golimumab 2 mg/kg | Total |
|---|---|---|---|
| Female | 118 | 113 | 231 |
| Male | 121 | 128 | 249 |
| Region of Enrollment(Participants) | Placebo (Week 0-24) | Golimumab 2 mg/kg | Total |
|---|---|---|---|
| Belarus | 14 | 8 | 22 |
| Canada | 1 | 0 | 1 |
| Germany | 3 | 1 | 4 |
| Hungary | 13 | 9 | 22 |
| Lithuania | 13 | 17 | 30 |
| Poland | 43 | 34 | 77 |
| Romania | 3 | 1 | 4 |
| Russian Federation | 79 | 74 | 153 |
| Spain | 1 | 2 | 3 |
| Ukraine | 61 | 86 | 147 |
| United States | 8 | 9 | 17 |
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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