A Phase 3 interventional study of Golimumab and Methotrexate in Rheumatoid Arthritis, sponsored by Centocor, Inc.. Completed at 72 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-29.
Sponsored by Centocor, Inc. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in patients with active rheumatoid arthritis (RA) despite concurrent MTX treatment. In addition, the safety of subcutaneous (SC) golimumab injections following transition from IV golimumab infusions will also be evaluated.
This is a Phase III, double blind (neither investigator nor participant knows the treatment received), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), multicenter, 5-arm (treatment groups) study of golimumab at 2 doses (given with or without MTX over a period of 30 minutes) for at least 48 weeks in patients with active RA despite concurrent MTX therapy. The study consists of a treatment period of golimumab IV infusions (IV Period) which ranges from 48 weeks to approximately 140 weeks, assuming an enrollment period of approximately 92 weeks, and a long-term optional extension period (Extension Study) in which golimumab SC injections will be given for 24 weeks. The end of study will be the time the last participant completes the Week E-40 visit (Extension Study) for safety follow-up assessments. For the IV Period, participants will be randomly assigned to 1 of the 5 treatment groups in a 1:1:1:1:1 ratio (approximately 125 patients per group). At Week 16 and Week 24, joint assessment results will be used to allow participants to enter early escape and dose regimen adjustment, respectively, in a blinded fashion. Treatment will be unblinded after the 48-week database lock and participants will be given the option to participate in the Extension Study and receive SC injections of 50mg golimumab (with or without MTX) every 4 weeks for an additional 24 weeks. Safety will be monitored throughout the study. The entire study duration (IV Period plus Extension Study) for each participant will range from 88 weeks up to 192 weeks, assuming an enrollment period of approximately 92 weeks.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 643 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Centocor, Inc. is the lead sponsor of 75 studies on the registry; none are open to participants now.
First submitted after Centocor, Inc. became part of Johnson & Johnson.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (an additional 2mg/kg IV infusion of golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive methotrexate (MTX) at the same dose as that before study entry
Drug: Golimumab · Drug: Methotrexate
IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX or switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive placebo (sham MTX) capsules
Drug: Golimumab · Drug: Placebo
IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive MTX at the same dose as that before study entry.
Drug: Golimumab · Drug: Methotrexate
IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter with early escape (addition of MTX) and dose regimen adjustment (addition of MTX), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (initial treatment plus early escape and/or dose regimen adjustment) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, patients will receive placebo (sham MTX) capsules.
Drug: Golimumab · Drug: Placebo
IV infusions of placebo at Week 0 and Week 12 with early escape (switch to 4mg/kg IV golimumab) and dose regimen adjustment (switch to 4mg/kg IV golimumab), depending on joint assessment results, at Week 16 and 24, respectively. The duration of the combined IV treatment period (placebo plus golimumab) will be a minimum of 48 weeks. The IV treatment period will be followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition patients will receive MTX at the same dose as that before study entry. Participants still receiving placebo injections at Week 48 are not eligible to enter the Extension Study.
Drug: Methotrexate · Drug: Placebo
2mg/kg or 4mg/kg will be administered as an IV infusion over 30 minutes
Active MTX capsules, filled with microcrystalline cellulose (Avicel PH 102) and a 2.5 mg MTX tablet, will be administered at the same dose as before the study entry.
Placebo solution will be administered through IV infusion in Group V and oral placebo capsules (sham MTX) filled with microcrystalline cellulose (Avicel PH 102) will be administered in Group II and IV.
Also known as: sham MTX
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14
An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
Time frame: Week 0 to Week 14
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24
ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).
Time frame: Week 0 to Week 24
Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14
ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity \[based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities\] and CRP blood test to measure inflammation).
Time frame: Week 0 to Week 14
Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14
DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A "Good" response is defined as a patient with a DAS28 score of \<= 3.2 at Week 14 with improvement from Baseline in DAS28 score of \> 1.2. A "Moderate" response is defined as a patient with DAS28 score of \>3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of \>1.2 or a DAS28 score of \<= 5.1 and improvement from baseline in DAS28 score of \>0.6 to 1.2
Time frame: Week 0 to Week 14
Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14
The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.
Time frame: Weeks 0 to Week 14
The study was conducted at 86 investigational sites. The study population included 643 randomized participants from 15 countries.
| Milestone | 2mg/kg Golimumab+ MTX | 2mg/kg Golimumab Only | 4mg/kg Golimumab + MTX | 4mg/kg Golimumab Only | IV Placebo + MTX | EE/DRA -> 2mg/kg Golimumab + MTX | EE/DRA -> 4mg/kg Golimumab + MTX |
|---|---|---|---|---|---|---|---|
| Started | 129 | 128 | 128 | 129 | 129 | 0 | 0 |
| Completed | 109 | 99 | 107 | 102 | 105 | 0 | 0 |
| Not completed | 20 | 29 | 21 | 27 | 24 | 0 | 0 |
| Withdrew: Adverse event | 9 | 4 | 5 | 9 | 8 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 2 | 2 | 0 | 0 |
| Withdrew: Death | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Discontinued oral study agent | 2 | 1 | 1 | 1 | 2 | 0 | 0 |
| Withdrew: Protocol-prohibited medications | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Worsening of ra | 0 | 5 | 1 | 4 | 2 | 0 | 0 |
| Withdrew: Other | 2 | 9 | 9 | 3 | 2 | 0 | 0 |
| Withdrew: Lack of efficacy | 5 | 9 | 3 | 7 | 8 | 0 | 0 |
| Milestone | 2mg/kg Golimumab+ MTX | 2mg/kg Golimumab Only | 4mg/kg Golimumab + MTX | 4mg/kg Golimumab Only | IV Placebo + MTX | EE/DRA -> 2mg/kg Golimumab + MTX | EE/DRA -> 4mg/kg Golimumab + MTX |
|---|---|---|---|---|---|---|---|
| Started | 82 | 59 | 104 | 63 | 3 | 24 | 173 |
| Completed | 80 | 56 | 99 | 59 | 3 | 23 | 164 |
| Not completed | 2 | 3 | 5 | 4 | 0 | 1 | 9 |
| Withdrew: Adverse event | 0 | 2 | 1 | 2 | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Worsening of ra | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Other | 1 | 0 | 0 | 1 | 0 | 1 | 2 |
| Withdrew: Lack of efficacy | 0 | 0 | 2 | 0 | 0 | 0 | 3 |
An ACR 50 response is defined as a greater than or equal to 50 percentage improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b. Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).
| Participants | Group I: 2mg/kg Golimumab+ MTX | Group II: 2mg/kg Golimumab Only | Group III: 4mg/kg Golimumab + MTX | Group IV: 4mg/kg Golimumab Only | Group V: IV Placebo + MTX | Group VI: Combined Groups I and III | Group VII: Combined Groups II and IV |
|---|---|---|---|---|---|---|---|
| Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 14 | 28 | 16 | 27 | 25 | 17 | 55 | 41 |
ACR 50 response is an improvement of greater than or equal to 50 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity (based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities) and CRP blood test to measure inflammation).
| Participants | Group I: 2mg/kg Golimumab+ MTX | Group II: 2mg/kg Golimumab Only | Group III: 4mg/kg Golimumab + MTX | Group IV: 4mg/kg Golimumab Only | Group V: IV Placebo + MTX | Group VI: Combined Groups I and III | Group VII: Combined Groups II and IV |
|---|---|---|---|---|---|---|---|
| Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24 | 24 | 11 | 32 | 15 | 12 | 56 | 26 |
ACR 20 response is an improvement of greater than or equal to 20 percentage from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain, patient's global assessemnt of disease activity, Physician's global assessment of disease activity \[based on a scale of 0=no disease to 10=severe disease), HAQ (20 questions on life activities\] and CRP blood test to measure inflammation).
| Participants | Group I: 2mg/kg Golimumab+ MTX | Group II: 2mg/kg Golimumab Only | Group III: 4mg/kg Golimumab + MTX | Group IV: 4mg/kg Golimumab Only | Group V: IV Placebo + MTX | Group VI: Combined Groups I and III | Group VII: Combined Groups II and IV |
|---|---|---|---|---|---|---|---|
| Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 14 | 71 | 51 | 66 | 62 | 36 | 137 | 113 |
DAS28 using CRP is a measure of tender and swollen joints (28 joints each) and the patient's assessment of disease activity. Values range from 0 (best) to 10 (worst). A score of higher than 5.1 indicates high disease activity, and a score below 3.2 indicates low disease activity. A "Good" response is defined as a patient with a DAS28 score of \<= 3.2 at Week 14 with improvement from Baseline in DAS28 score of \> 1.2. A "Moderate" response is defined as a patient with DAS28 score of \>3.2-5.1 at Week 14 with improvement from baseline in DAS28 score of \>1.2 or a DAS28 score of \<= 5.1 and improvement from baseline in DAS28 score of \>0.6 to 1.2
| Participants | Group I: 2mg/kg Golimumab+ MTX | Group II: 2mg/kg Golimumab Only | Group III: 4mg/kg Golimumab + MTX | Group IV: 4mg/kg Golimumab Only | Group V: IV Placebo + MTX | Group VI: Combined Groups I and III | Group VII: Combined Groups II and IV |
|---|---|---|---|---|---|---|---|
| Number of Participants With a Disease Activity Index Score 28 (Using C-reactive Protein)Moderate or Good Response at Week 14 | 89 | 80 | 94 | 83 | 57 | 183 | 163 |
The SF-36 consists of 8 multi-item scales: limitations in physical functioning due to health problems, usual role activities due to physical health problems, bodily pain, usual role activities due to personal or emotional problems, social functioning due to physical or mental health problems, general mental health (psychological distress and well-being), vitality and general health perception. The values are 100=best to 0=worst.
| Units on a scale | Group I: 2mg/kg Golimumab+ MTX | Group II: 2mg/kg Golimumab Only | Group III: 4mg/kg Golimumab + MTX | Group IV: 4mg/kg Golimumab Only | Group V: IV Placebo + MTX | Group VI: Combined Groups I and III | Group VII: Combined Groups II and IV |
|---|---|---|---|---|---|---|---|
| Physical Component Summary (PCS) Score of the Short Form-36 (SF-36) at Week 14 | 6.92 ± 9.175 | 4.03 ± 7.462 | 6.76 ± 8.252 | 5.14 ± 9.674 | 4.27 ± 7.216 | 6.84 ± 8.702 | 4.58 ± 8.644 |
Collected over IV Period: Baseline through Week 48 for all participants, and up to the start of the SC Period (Week E0) for participants who opted to enter the SC Period (Extension Study). SC Period: Week E0 through Week E40.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IV Period: 2mg/kg Golimumab+ MTX | — | 25/182 (13.7%) | 109/182 (59.9%) |
| IV Period: 2mg/kg Golimumab Only | — | 17/128 (13.3%) | 71/128 (55.5%) |
| IV Period: 4mg/kg Golimumab + MTX | — | 47/336 (14%) | 190/336 (56.5%) |
| IV Period: 4mg/kg Golimumab Only | — | 8/127 (6.3%) | 70/127 (55.1%) |
| IV Period: Placebo + MTX | — | 7/129 (5.4%) | 65/129 (50.4%) |
| SC Period: 50mg Golimumab + MTX | — | 38/419 (9.1%) | 94/419 (22.4%) |
| SC Period: 50mg Golimumab Only | — | 8/117 (6.8%) | 26/117 (22.2%) |
| Event | IV Period: 2mg/kg Golimumab+ MTX | IV Period: 2mg/kg Golimumab Only | IV Period: 4mg/kg Golimumab + MTX | IV Period: 4mg/kg Golimumab Only | IV Period: Placebo + MTX | SC Period: 50mg Golimumab + MTX | SC Period: 50mg Golimumab Only |
|---|---|---|---|---|---|---|---|
| Coronary artery diseaseCardiac disorders | 0/182 | 0/128 | 0/336 | 1/127 | 1/129 | 0/419 | 3/117 |
| PneumoniaInfections and infestations | 1/182 | 3/128 | 3/336 | 1/127 | 1/129 | 5/419 | 0/117 |
| CellulitisInfections and infestations | 0/182 | 1/128 | 4/336 | 0/127 | 0/129 | 2/419 | 0/117 |
| Tendon ruptureInjury, poisoning and procedural complications | 2/182 | 0/128 | 0/336 | 0/127 | 0/129 | 0/419 | 0/117 |
| DepressionPsychiatric disorders | 2/182 | 0/128 | 0/336 | 0/127 | 0/129 | 0/419 | 0/117 |
| Urinary tract infectionInfections and infestations | 0/182 | 0/128 | 3/336 | 0/127 | 0/129 | 2/419 | 0/117 |
| Myocardial infarctionCardiac disorders | 1/182 | 0/128 | 1/336 | 0/127 | 0/129 | 1/419 | 1/117 |
| Acute myocardial infarctionCardiac disorders | 0/182 | 0/128 | 1/336 | 0/127 | 0/129 | 0/419 | 1/117 |
| SyncopeNervous system disorders | 0/182 | 0/128 | 0/336 | 0/127 | 1/129 | 1/419 | 1/117 |
| Upper respiratory tract infectionInfections and infestations | 0/182 | 0/128 | 0/336 | 1/127 | 0/129 | 0/419 | 1/117 |
| Event | IV Period: 2mg/kg Golimumab+ MTX | IV Period: 2mg/kg Golimumab Only | IV Period: 4mg/kg Golimumab + MTX | IV Period: 4mg/kg Golimumab Only | IV Period: Placebo + MTX | SC Period: 50mg Golimumab + MTX | SC Period: 50mg Golimumab Only |
|---|---|---|---|---|---|---|---|
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 12/182 | 20/128 | 19/336 | 12/127 | 6/129 | 29/419 | 6/117 |
| Upper respiratory tract infectionInfections and infestations | 22/182 | 14/128 | 41/336 | 16/127 | 12/129 | 30/419 | 10/117 |
| NauseaGastrointestinal disorders | 20/182 | 4/128 | 36/336 | 7/127 | 9/129 | 10/419 | 1/117 |
| HeadacheNervous system disorders | 17/182 | 8/128 | 26/336 | 8/127 | 13/129 | 20/419 | 2/117 |
| DiarrhoeaGastrointestinal disorders | 15/182 | 4/128 | 14/336 | 7/127 | 2/129 | 15/419 | 4/117 |
| Alanine aminotransferase increasedInvestigations | 15/182 | 3/128 | 19/336 | 3/127 | 8/129 | 18/419 | 3/117 |
| BronchitisInfections and infestations | 14/182 | 10/128 | 26/336 | 8/127 | 7/129 | 22/419 | 2/117 |
| InfluenzaInfections and infestations | 6/182 | 10/128 | 10/336 | 5/127 | 1/129 | 15/419 | 3/117 |
| NasopharyngitisInfections and infestations | 13/182 | 9/128 | 13/336 | 8/127 | 7/129 | 19/419 | 9/117 |
| HypertensionVascular disorders | 14/182 | 8/128 | 15/336 | 4/127 | 5/129 | 7/419 | 1/117 |
| Age, Continuous(years) | 2mg/kg Golimumab+ MTX | 2mg/kg Golimumab Only | 4mg/kg Golimumab + MTX | 4mg/kg Golimumab Only | IV Placebo + MTX | Total |
|---|---|---|---|---|---|---|
| Mean | 49.7 ± 11.10 | 49.9 ± 11.86 | 49.6 ± 10.96 | 48.4 ± 12.66 | 50.2 ± 11.28 | 49.4 ± 11.65 |
| Sex: Female, Male(Participants) | 2mg/kg Golimumab+ MTX | 2mg/kg Golimumab Only | 4mg/kg Golimumab + MTX | 4mg/kg Golimumab Only | IV Placebo + MTX | Total |
|---|---|---|---|---|---|---|
| Female | 99 | 107 | 103 | 105 | 103 | 517 |
| Male | 30 | 21 | 25 | 24 | 26 | 126 |
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Studies of the drugs tested here: Golimumab · Methotrexate