Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015845-21 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Experimental | Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. |
|
| Adalimumab 40 mg | Active Comparator | Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) | The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US). | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24 | The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported. | Week 24 |
| Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston | Alabama | 36207 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28955499 | Derived | Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017. | |
| 26613768 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab 8 mg/kg | Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. |
| FG001 | Adalimumab 40 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Adalimumab | Drug |
|
| Placebo to tocilizumab | Drug |
|
| Placebo to adalimumab | Drug |
|
The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported. |
| Week 24 |
| Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24 | Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" [symptom-free and no arthritis symptoms] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate. | Baseline to Week 24 |
| Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24 | Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2. | Baseline to Week 24 |
| Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 | Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2. | Baseline to Week 24 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Scottsdale | Arizona | 85258 | United States |
| Hot Springs | Arkansas | 71913 | United States |
| Little Rock | Arkansas | 72205 | United States |
| San Diego | California | 92108 | United States |
| Colorado Springs | Colorado | 80910 | United States |
| Trumbull | Connecticut | 06611 | United States |
| Boca Raton | Florida | 33486 | United States |
| Fort Lauderdale | Florida | 33334 | United States |
| Ormond Beach | Florida | 32174 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Springfield | Illinois | 62704 | United States |
| Cumberland | Maryland | 21502 | United States |
| Flowood | Mississippi | 39232 | United States |
| Tupelo | Mississippi | 38802 | United States |
| Lincoln | Nebraska | 68516 | United States |
| Dover | New Hampshire | 03820 | United States |
| New Brunswick | New Jersey | 08903 | United States |
| Hickory | North Carolina | 28601 | United States |
| Dayton | Ohio | 45402 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Willow Grove | Pennsylvania | 19090 | United States |
| Wyomissing | Pennsylvania | 19610 | United States |
| Greenville | South Carolina | 29601 | United States |
| Hixson | Tennessee | 37343 | United States |
| Houston | Texas | 77074 | United States |
| Lubbock | Texas | 79424 | United States |
| Mesquite | Texas | 75150 | United States |
| Nassau Bay | Texas | 77058 | United States |
| Waco | Texas | 76708 | United States |
| Spokane | Washington | 99204 | United States |
| Tacoma | Washington | 98405 | United States |
| Maroochydore | 4558 | Australia |
| Sydney | 2050 | Australia |
| Brussels | 1070 | Belgium |
| Liège | 4000 | Belgium |
| Curitiba | 80060-240 | Brazil |
| Goiânia | 74110010 | Brazil |
| São Paulo | 04266-010 | Brazil |
| Prague | 12850 | Czechia |
| Helsinki | 00290 | Finland |
| Jyväskylä | 40100 | Finland |
| Baden-Baden | 76530 | Germany |
| Berlin | 14059 | Germany |
| Cologne | 50924 | Germany |
| Essen | 45239 | Germany |
| Heidelberg | 69120 | Germany |
| Herne | 44652 | Germany |
| Hildesheim | 31134 | Germany |
| Osnabrück | 49074 | Germany |
| Ratingen | 40882 | Germany |
| Würzburg | 97080 | Germany |
| Athens | 11527 | Greece |
| Heraklion | 71110 | Greece |
| Thessaloniki | 54642 | Greece |
| Mexicali | 21100 | Mexico |
| Mexico City | 11850 | Mexico |
| Obregón | 85000 | Mexico |
| Almada | 2801-951 | Portugal |
| Lisbon | 1649-035 | Portugal |
| Porto | 4200-319 | Portugal |
| A Coruña | 15006 | Spain |
| Barcelona | 08036 | Spain |
| Madrid | 28006 | Spain |
| Santiago de Compostela | 15705 | Spain |
| Seville | 41009 | Spain |
| Stockholm | 17176 | Sweden |
| Uppsala | 751 85 | Sweden |
| Aarau | 5000 | Switzerland |
| Geneva | 1211 | Switzerland |
| Lausanne | 1011 | Switzerland |
| Sankt Gallen | 9007 | Switzerland |
| Zurich | 8091 | Switzerland |
| Ankara | 06100 | Turkey (Türkiye) |
| Antalya | 07059 | Turkey (Türkiye) |
| Istanbul | 34098 | Turkey (Türkiye) |
| Cannock | WS11 5XY | United Kingdom |
| Leeds | LS7 4SA | United Kingdom |
| London | E11 1NR | United Kingdom |
| Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Poole | BH15 2JB | United Kingdom |
| Gabay C, McInnes IB, Kavanaugh A, Tuckwell K, Klearman M, Pulley J, Sattar N. Comparison of lipid and lipid-associated cardiovascular risk marker changes after treatment with tocilizumab or adalimumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2016 Oct;75(10):1806-12. doi: 10.1136/annrheumdis-2015-207872. Epub 2015 Nov 27. |
| 25167216 | Derived | Dennis G Jr, Holweg CT, Kummerfeld SK, Choy DF, Setiadi AF, Hackney JA, Haverty PM, Gilbert H, Lin WY, Diehl L, Fischer S, Song A, Musselman D, Klearman M, Gabay C, Kavanaugh A, Endres J, Fox DA, Martin F, Townsend MJ. Synovial phenotypes in rheumatoid arthritis correlate with response to biologic therapeutics. Arthritis Res Ther. 2014;16(2):R90. doi: 10.1186/ar4555. Epub 2014 Apr 30. |
| 23515142 | Derived | Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, Klearman M, Musselman D, Agarwal S, Green J, Kavanaugh A; ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013 May 4;381(9877):1541-50. doi: 10.1016/S0140-6736(13)60250-0. Epub 2013 Mar 18. |
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab 8 mg/kg | Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. |
| BG001 | Adalimumab 40 mg | Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks. |
| 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 | Baseline Characteristics were analyzed for the intent-to-treat (ITT) population which included all randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. One randomized patient in the adalimumab treatment group did not receive treatment and was not included in any of the data analyses, including demographics. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Baseline Characteristics were analyzed for the intent-to-treat (ITT) population which included all randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. One randomized patient in the adalimumab treatment group did not receive treatment and was not included in any of the data analyses, including demographics. | 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 to Week 24 in the Disease Activity Score 28 (DAS28) | The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and > 2 years) and region (US and non-US). | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. | Posted | Mean | 95% Confidence Interval | Units on a scale | Baseline to Week 24 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24 | The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score < 2.6, is reported. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. | Posted | Number | Percentage of patients | Week 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24 | The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. | Posted | Number | Percentage of patients | Week 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24 | Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" [symptom-free and no arthritis symptoms] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. | Posted | Number | Percentage of patients | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24 | Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. | Posted | Number | Percentage of patients | Baseline to Week 24 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24 | Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2. | Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment. | Posted | Number | Percentage of patients | Baseline to Week 24 |
|
Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
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 | Tocilizumab 8 mg/kg | Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks. | 19 | 162 | 66 | 162 | ||
| EG001 | Adalimumab 40 mg | Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks. | 16 | 162 | 65 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Infective tenosynovitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Viral labyrinthitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Intervertebral disc protusion | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
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 | Hoffmann-La Roche | 800 821-8590 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| 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 |
|---|---|
| C502936 | tocilizumab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| 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 |
Not provided
Not provided
| Male |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|