AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT03981055 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: Sham Comparator: Sham TDCS and Sham TUS
Description: Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.~Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Study NCT01827228 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: HIV medical care
Description: This will be expedited and assisted via community outreach for Recents and Acutes
Study NCT01827228 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: HIV medical care
Description: This will be expedited and assisted via community outreach for Recents and Acutes
Study NCT01827228 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Social network and venue tracing
Description: This is described in Arms 1 and 2
Study NCT01827228 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Social network and venue tracing
Description: This is described in Arms 1 and 2
Study NCT01827228 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Community alerts
Description: When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions
Study NCT03273075 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Ticagrelor
Description: The intervention comprises the standard P2Y12-blocker ticagrelor therapy if prasugrel is contraindicated and no contraindication to ticagrelor is present.
Study NCT01827228 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Community alerts
Description: When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions
Study NCT01827228 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Community education
Description: Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma
Study NCT03981055 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Physical Therapy
Description: All subjects will enroll in a conventional PT balance and gait focused training program, and will receive PT 3x/week over the two weeks of stimulation for 45 minutes following the stimulation sessions when applicable. (And during the biweekly sessions for Phase II)
Study NCT01827228 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Community education
Description: Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma
Study NCT01827228 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: HIV counseling
Description: As part of HIV testing, we will provide participants with standard counseling
Study NCT00815269 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Halothane
Description: Induction: 2-4% halothane pluses 3-5 L/min oxygen Maintenance: different doses from 0.5% to 3% with 1-2 L/min oxygen
Study NCT00815269 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Isoflurane
Description: Induction: 2-5% isoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Study NCT00815269 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sevoflurane
Description: Induction: 3-8% sevoflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Study NCT00815269 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Desflurane
Description: Induction: 2-8% desflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Study NCT00815269 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Enflurane
Description: Induction: 2-5% enflurane pluses 3-5 L/min oxygen Maintenance: different doses from 1% to 4% with 1-2 L/min oxygen
Study NCT01563744 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: EGD-assisted administration of colonoscopy prep
Description: Interventional group receive the first 2 liters of prep solution during EGD through the scope channel if colonoscopy expected the following day.
Study NCT01563744 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Control Group received standard prep by oral administration
Description: Control group receive standard oral colonoscopy prep.
Study NCT01296360 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: IXIARO
Description: 0.25 ml i.m. (milliliter, intramuscular)
Study NCT01296360 — intervention group
Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: IXIARO
Description: 0.5 ml i.m. (milliliter, intramuscular)
Study NCT02835560 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy
Description: Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid
Study NCT02835560 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy
Description: Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
Study NCT01474369 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438
Description: TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
Study NCT01474369 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: TAK-438
Description: TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
Study NCT01474369 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.
Study NCT03824171 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Raloxifene 60mg/Cholecalciferol 800IU
Description: Raloxifene 60mg/Cholecalciferol 800IU tablet
Study NCT03824171 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: AD-102
Description: AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet
Study NCT01827228 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: HIV counseling
Description: As part of HIV testing, we will provide participants with standard counseling
Study NCT00487721 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Silibin-Phytosome
Description: Subjects will take Silibin-Phytosome for 2-10 weeks. The dose of Silibin-Phytosome is 13 grams daily, in three divided doses. Patients will be asked to mix 1 level teaspoon and 1 heaping ¼ teaspoon of Silybin-Phytosome powder into 6 tablespoons of applesauce for each dose.
Study NCT00073957 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: rituximab
Study NCT00073957 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: cytarabine
Description: to be used for CNS prophylaxis
Study NCT00073957 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: liposomal cytarabine
Description: to be used as CNS prophylaxis
Study NCT03981055 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: Physical Therapy
Description: All subjects will enroll in a conventional PT balance and gait focused training program, and will receive PT 3x/week over the two weeks of stimulation for 45 minutes following the stimulation sessions when applicable. (And during the biweekly sessions for Phase II)
Study NCT00073957 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: yttrium Y 90 ibritumomab tiuxetan
Study NCT02295982 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Hand assisted laparoscopic nephrectomy
Description: patients with renal cancer will undergo hans assisted laparoscopic nephrectomy
Study NCT02295982 — intervention group
Intervention type: PROCEDURE
Group type: PLACEBO_COMPARATOR
Intervention: Hand assisted laparoscopic nephrectomy
Description: patients with renal cancer will undergo hans assisted laparoscopic nephrectomy
Study NCT00530777 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: valacyclovir
Description: 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
Study NCT00530777 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: placebo
Description: oral placebo twice daily from 34 weeks gestation to 1 year postpartum
Study NCT01199731 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2248761 100 mg once daily
Description: 1 100mg capsule OAD plus matching placebo
Study NCT01199731 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2248761 200 mg once daily
Description: 2 100mg capsules OAD
Study NCT01199731 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Etravirine
Description: 2 100mg tablets twice daily
Study NCT02394548 — intervention group
Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: Contralateral Esophageal Sparing Technique (CEST)
Description: Determine whether CEST decreases rate of severe acute esophagitis
Study NCT03688009 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Mindfulness-Based Family Psycho-Education (MBFBE)
Description: Six sessions includes: 1. Working with Caregiving Stress; 2. The Struggles of a Caregiver; 3. The Struggles of a Person in Recovery; 4. The Path of Recovery; 5. A Supportive Caregiving; and 6. Review of Learning.
Study NCT02427737 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Comfort Talk® Training
Description: Personnel of MRI units is trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This entails 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.
Study NCT03738358 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Trehalose
Description: 80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g
Study NCT03738358 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g
Study NCT03267147 — intervention group
Intervention type: OTHER
Intervention: no intervention is given
Description: no intervention is given
Study NCT02060097 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Cocoa flavanol beverage
Study NCT02060097 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo beverage
Study NCT02833454 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: direct insertion anterior cruciate ligament reconstruction
Description: ACL reconstruction based on direct insertion of ACL.
Study NCT03688009 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Family Psycho-Education (FPE)
Description: Six sessions includes: 1. Working with Caregiving Stress; 2. The Struggles of a Caregiver; 3. The Struggles of a Person in Recovery; 4. The Path of Recovery; 5. A Supportive Caregiving; and 6. Review of Learning.
Study NCT02833454 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: single bundle anterior cruciate ligament reconstruction
Description: anterior cruciate ligament reconstruction using single bundle technique
Study NCT02833454 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: single bundle anterior cruciate ligament reconstruction
Description: anterior cruciate ligament reconstruction using single bundle technique
Study NCT02833454 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: double bundle anterior cruciate ligament reconstruction
Description: anterior cruciate ligament reconstruction using double bundle technique
Study NCT02833454 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: double bundle anterior cruciate ligament reconstruction
Description: anterior cruciate ligament reconstruction using double bundle technique
Study NCT00602160 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: FAHF-2 (TM)
Description: We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group.~Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy.
Study NCT00602160 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: FAHF-2 (TM)
Description: We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group.~Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy.
Study NCT01904357 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cefazolin 1 GM Injection
Description: Subjects weighing ≥25 kg and \< 50 kg will receive the 1g dose.
Study NCT01904357 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cefazolin 2 GM Injection
Description: Subjects weighing ≥50 kg to ≤85 kg will receive the 2g dose.
Study NCT03382821 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transforaminal ESI with dexamethasone
Description: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
Study NCT03382821 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Transforaminal catheter-targeted ESI with triamcinolone
Description: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
Study NCT03382821 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Dexamethasone Sodium Phosphate 10 MG/ML
Description: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
Study NCT03382821 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Lidocaine
Description: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
Study NCT03382821 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Triamcinolone Acetonide 40mg/mL
Description: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
Study NCT01140347 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: 8 mg/kg IV every 2 weeks
Study NCT03985384 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Semaglutide 2 MG/1.5 ML Subcutaneous Solution
Description: Semaglutide 2 MG/1.5 ML Subcutaneous Solution
Study NCT03985384 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Placebo 1.5 ml, pen-injector for SC injection.
Study NCT01140347 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Ramucirumab DP (IMC-1121B)
Description: 8 milligrams/kilogram (mg/kg) intravenous (IV) every 2 weeks
Study NCT01140347 — intervention group
Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: BSC
Description: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
Study NCT01140347 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: BSC
Description: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
Study NCT01805323 — intervention group
Intervention type: DRUG
Intervention: Dexamethasone Intravitreal Implant
Description: Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.
Study NCT03867864 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Necklace with essential oil for the first 4 weeks
Description: The necklaces contain essential oil.
Study NCT03867864 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Necklace without essential oil for the first 4 weeks
Description: The necklaces do not contain essential oil.
Study NCT03867864 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Washout
Description: Washout (do not wear the necklace) for one week for two groups, then two groups cross-over.
Study NCT03867864 — intervention group
Intervention type: OTHER
Group type: OTHER
Intervention: Washout
Description: Washout (do not wear the necklace) for one week for two groups, then two groups cross-over.
Study NCT03867864 — intervention group
Intervention type: DEVICE
Group type: OTHER
Intervention: Necklace with essential oil for last 4 weeks
Description: The necklaces contain essential oil.
Study NCT03867864 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Necklace without essential oil for last 4 weeks
Description: The necklaces do not contain essential oil.
Study NCT01141660 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Endotracheal Tube
Description: Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.
Study NCT01141660 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Laryngeal mask airway
Description: Randomized to either Laryngeal mask airway or endotracheal tube
Study NCT01791426 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Artelac Rebalance
Description: Instill 1 drop of the Artelac Rebalance eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.
Study NCT01791426 — intervention group
Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: Vismed
Description: Instill 1 drop of the Vismed eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.
Study NCT02876146 — intervention group
Intervention type: DRUG
Group type: OTHER
Intervention: Benzimidazole
Description: Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)
Study NCT03098264 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Simultaneous surgery
Description: Simultaneous surgery in complicated hepatolithiasis
Study NCT03098264 — intervention group
Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: staged surgery
Description: staged surgery in complicated hepatolithiasis
Study NCT03519321 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: MID-C
Description: The MID-C system is being connected to the spine via standard unilateral posterior approach. Pedicle screws above and below the main curve are being used to attach the device to the selected vertebra.
Study NCT01513356 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BKM120
Description: BKM120 will be administered on a continuous once daily dosing schedule at a dose of 100 mg (p.o.)until progression of disease or unacceptable toxicity or a maximum of 4 weeks.
Study NCT02215798 — intervention group
Intervention type: DRUG
Intervention: Cymbalta
Study NCT03935828 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oral versus topical antibioitics
Description: Previously described in two arms
Study NCT03935828 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oral versus topical antibioitics
Description: Previously described in two arms
Study NCT03186937 — intervention group
Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: hominex-2
Description: Hominex-2 is a methionine-free amino acid modified medical supplement
Study NCT01111890 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Azarga (brinzolamide 1% / timolol 0.5%)
Description: Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
Study NCT01111890 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cosopt (dorzolamide 2% / timolol 0.5%)
Description: Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
Study NCT03737253 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Follitropin alpha
Description: The objective is to measure the effect of the drug according to gonadotropin receptor genotype.
Study NCT03737253 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Menotropin
Description: The objective is to measure the effect of the drug according to gonadotropin receptor genotype.
Study NCT02049437 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: tocilizumab
Description: Subjects will be randomized 1:1 to one of the following arms:~ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 and 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.~ARM B: Placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 minutes once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28.