Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GA00931 |
Not provided
Not provided
Not provided
Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.
Not provided
Not provided
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab 200mg | Experimental | Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. |
|
| Infliximab 5mg/kg | Active Comparator | Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Intravenous repeating dose |
| |
| Methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in DAS28(ESR) at Week 20 | Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response of 20% According to ACR Criteria | Baseline up to 30 months | |
| Percentage of Participants With Clinical Response of 50% According to ACR Criteria | Baseline up to 30 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Associates | Birmingham | Alabama | 35205 | United States | ||
| NEA Baptist Clinic |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocrelizumab 200mg | Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Period + 48 Weeks of Follow-up |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Oral or parenteral repeating dose |
|
| Methylprednisolone | Drug | Intravenous repeating dose |
|
| Ocrelizumab | Drug | Intravenous repeating dose |
|
| Placebo | Drug | Intravenous repeating dose |
|
| Percentage of Participants With Clinical Response of 70% According to ACR Criteria | Baseline up to 30 months |
| European League Against Rheumatism (EULAR) Response Rates | Baseline up to 30 months |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline up to 30 months |
| Change in Fatigue Visual Analog Scale Score (VAS) | Baseline up to 30 months |
| Percentage of Participants With Adverse Events (AEs) | Baseline up to 30 months |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Dr. Brigid Freyne, MD | Murrieta | California | 92563 | United States |
| Agilence Arthritis and Osteoporosis Medical Center, Inc. | Whittier | California | 90606 | United States |
| Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs | Colorado Springs | Colorado | 80920 | United States |
| RASF-Clinical Research Center | Boca Raton | Florida | 33486 | United States |
| Robert W. Levin MD - PP | Dunedin | Florida | 34698 | United States |
| Science and Research Institute, Inc. | Jupiter | Florida | 33458 | United States |
| Rheumatology Associates of Central Florida | Orlando | Florida | 32806 | United States |
| Lovelace Scientific Resources | Sarasota | Florida | 34292 | United States |
| Arthritis Res & Treatment | Macon | Georgia | 30281 | United States |
| Harbin Clinic | Rome | Georgia | 30165 | United States |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | United States |
| Illinois Bone & Joint Inst. | Morton Grove | Illinois | 60053 | United States |
| Springfield Clinic | Springfield | Illinois | 62703 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01610 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Rheumatology, P.C.; Medical Arts Building | Kalamazoo | Michigan | 49009 | United States |
| Fiechtner Research Inc | Lansing | Michigan | 48910 | United States |
| Shores Rheumatology | Saint Clair Shores | Michigan | 48081 | United States |
| Jackson Arthritis Clinic | Flowood | Mississippi | 39232 | United States |
| Arthritis Associates of Mississippi | Jackson | Mississippi | 39202 | United States |
| Private Practice - Rosenberg | Florissant | Missouri | 63031 | United States |
| Clayton Medical Research | St Louis | Missouri | 63117 | United States |
| Billings Clinic; Research Center | Billings | Montana | 59101 | United States |
| Billings Clinic | Billings | Montana | 59102 | United States |
| Westroads Medical Group | Omaha | Nebraska | 68114 | United States |
| Arthritis Center of Reno | Reno | Nevada | 89502 | United States |
| Dartmouth-Hitchcock Medical Center, Rheumatology 5C | Lebanon | New Hampshire | 03756 | United States |
| Regional Clinical Research | Binghamton | New York | 13905 | United States |
| Arthritis & Osteoporosis Center | Brooklyn | New York | 11201 | United States |
| Southern Tier Arthritis & Rheumatism | Olean | New York | 14760 | United States |
| Buffalo Rheumatology Associates | Orchard Park | New York | 14127 | United States |
| Barada,Harrell,Toohey&Bellhorn | Durham | North Carolina | 27704 | United States |
| Physicians East Pa | Greenville | North Carolina | 27834 | United States |
| Ohio State Univ Med Center | Columbus | Ohio | 43210 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | United States |
| Providence Arthritis Center | Portland | Oregon | 97213 | United States |
| Lehigh Valley Physicians Group | Allentown | Pennsylvania | 18103 | United States |
| Arthritis Associates | Erie | Pennsylvania | 16508 | United States |
| Columbia Arthritis Center (Partnership Practice) | Columbia | South Carolina | 29204 | United States |
| Piedmont Arthritis Clinic | Greenville | South Carolina | 29601 | United States |
| South Carolina Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Arthritis Associates | Hixson | Tennessee | 37343 | United States |
| Ramesh Gupta - PP | Memphis | Tennessee | 38119 | United States |
| Ctr for Inflammatory Disease | Nashville | Tennessee | 37205 | United States |
| Amarillo Center For Clinical Research | Amarillo | Texas | 79124 | United States |
| Phillip A Waller MD, PA | Houston | Texas | 77034 | United States |
| Southwest Rheumatology | Mesquite | Texas | 75150 | United States |
| Texas Arthritis Research Center | San Antonio | Texas | 78217 | United States |
| FG001 | Infliximab 5mg/kg | Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind TX Period |
|
|
| Open Label Ocrelizumab Treatment Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ocrelizumab 200mg | Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. |
| BG001 | Infliximab 5mg/kg | Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in DAS28(ESR) at Week 20 | The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints. | Posted | Week 20 |
|
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response of 20% According to ACR Criteria | The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints. | Posted | Baseline up to 30 months |
|
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response of 50% According to ACR Criteria | The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints. | Posted | Baseline up to 30 months |
|
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response of 70% According to ACR Criteria | The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints. | Posted | Baseline up to 30 months |
|
| |||||||||||||||||||||||
| Secondary | European League Against Rheumatism (EULAR) Response Rates | The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints. | Posted | Baseline up to 30 months |
|
| |||||||||||||||||||||||
| Secondary | Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints. | Posted | Baseline up to 30 months |
|
| |||||||||||||||||||||||
| Secondary | Change in Fatigue Visual Analog Scale Score (VAS) | The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints. | Posted | Baseline up to 30 months |
|
| |||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | Posted | Number | Percentage of Participants | Baseline up to 30 months |
|
|
Baseline up to 43 months
4 patients from infliximab switched to ocrelizumab during the open label phase and the summary of AEs were summarized in the ocrelizumab arm for the safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ocrelizumab 200mg | Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. | 0 | 19 | 2 | 19 | 15 | 19 |
| EG001 | Infliximab 5mg/kg | Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. | 0 | 13 | 0 | 13 | 10 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| UPPER RESPIRATORY TRACT INFECTIOn | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| ALVEOLAR OSTEITIS | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| ORAL INFECTION | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| TOOTH ABSCESS | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA v15.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| FIBROMYALGIA | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| COLD SWEAT | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| ROSACEA | Skin and subcutaneous tissue disorders | MedDRA v15.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA v15.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v15.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA v15.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA v15.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA v15.1 | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA v15.1 | Systematic Assessment |
| |
| HEAD TITUBATION | Nervous system disorders | MedDRA v15.1 | Systematic Assessment |
| |
| RESTLESS LEGS SYNDROME | Nervous system disorders | MedDRA v15.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA v15.1 | Systematic Assessment |
| |
| HEART RATE INCREASED | Investigations | MedDRA v15.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA v15.1 | Systematic Assessment |
| |
| BENIGN NEOPLASM OF THYROID GLAND | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.1 | Systematic Assessment |
| |
| TOOTH EXTRACTION | Surgical and medical procedures | MedDRA v15.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA v15.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA v15.1 | Systematic Assessment |
| |
| JOINT DISLOCATION | Musculoskeletal and connective tissue disorders | MedDRA v15.1 | Systematic Assessment |
|
At the time of study termination the scope of the statistical analyses was reduced and limited to evaluation of the safety profile.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | F. Hoffmann-La Roche Ltd | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D008727 | Methotrexate |
| D008775 | Methylprednisolone |
| C533411 | ocrelizumab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Other reasons outside Sponsor decision |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|