protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT02261727 | 8.2 | The Global Burden of COPD | *8.2 The Global Burden of COPD*
In recent studies using standardised methodology including spirometry, the prevalence rates across the world for Global Initiative for Obstructive Lung Disease (GOLD) stage II to IV ranged from 6-19% of the population 2-3 . The morbidity of COPD is considerable. Estimates of the years o... | [] |
NCT02261727 | 8.3 | Risk Factors for COPD | *8.3 Risk Factors for COPD*
Cigarette smoking and exposure to smoke from combustion of biomass fuels are the most common causes of COPD. While cigarette smoking is the most common cause in Western countries, both causes are common in Asia and the developing world4 . Whilst the prevalence of smoking in women in most As... | [] |
NCT02261727 | 8.4 | Treatment for COPD | *8.4 Treatment for COPD*
Treatment for COPD involves a number of modalities including pharmacological treatment (bronchodilators and anti-inflammatory agents), pulmonary rehabilitation, vaccination against influenza, and domiciliary oxygen and lung volume reduction surgery for severe and endstage disease 1 . | [] |
NCT02261727 | 8.4.1 | Currently Recommended Pharmacological Treatment for COPD | The mainstay of pharmacological treatment is the early and sustained use of bronchodilators, and the later introduction of inhaled corticosteroids. The current GOLD evidence -based guidelines for COPD1 recommend short and long acting bronchodilators (beta agonists and muscarinic antagonists) alone or in combination for... | [] |
NCT02261727 | 8.4.1.1 | Limitations of Current Pharmacological Treatment | Short-acting beta agonists, LABAs and LAMAs are effective in reducing airway smooth muscle tone and offer relief of breathlessness, improve quality of life and reduce exacerbations. However, COPD is an inflammatory disease of the lungs with extra-pulmonary inflammatory manifestations15-18. The anti-inflammatory agents ... | [] |
NCT02261727 | 8.4.1.2 | The High Cost of Current Pharmacological Treatment | Tiotropium and combination therapies of ICS and LABAs are expensive and impose a large financial burden on patients in low-income countries and on governments in countries which provide full or partial cover for the cost of medications. In Australia, the total cost of COPD is estimated to be ~\$A8.8 billion 6, with the... | [] |
NCT02261727 | 8.5 | Rationale for the Proposed Study | *8.5 Rationale for the Proposed Study*
ICS have very limited efficacy in COPD and hence there is a large effort by the pharmaceutical industry to find more effective agents. Even if these efforts bear fruit it is highly likely that the new agents will be expensive and will continue to impose a large financial burden a... | [] |
NCT02261727 | 8.6 | Intervention Plan | *8.6 Intervention Plan*
This study will assess the efficacy of two relatively inexpensive treatment options already widely available around the world: oral theophylline and oral corticosteroids (prednisone). The study will test low dose theophylline administered in combination with low dose prednisone, compared to pla... | [] |
NCT02261727 | 9 | Study Design | [] | |
NCT02261727 | 9.1 | Hypothesis and Aims | *9.1 Hypothesis and Aims*
We hypothesise that patients with COPD will have beneficial responses to combination of low dose theophylline and low dose prednisone, superior to placebo reflected by a range of clinically important outcomes.
Further we hypothesise that there will be no significant increase in serious adver... | [] |
NCT02261727 | 9.2 | Study Treatments | *9.2 Study Treatments*
This randomised clinical trial will be conducted with a 3-arm blinded, double dummy comparison:
- Arm 1. Placebo (twice a day) + placebo (once a day)
- Arm 2. Theophylline 100mgs (twice a day) and placebo (once a day)
- Arm 3. Theophylline 100mgs (twice a day) and prednisone 5 mgs (once a day) | [] |
NCT02261727 | 9.2.1 | Permitted Concurrent Therapy | Patients may continue on the following:
- regular inhaled LAMA or LABA therapy
- short acting anticholinergic inhaled medication
- short acting beta agonist (SABA) inhaled rescue medication | [] |
NCT02261727 | 9.2.2 | Non-Permitted Concurrent Therapy | The following maintenance medications are not permitted during the study:
- Inhaled corticosteroids, except at exacerbation for maximum seven (7) days
- Daily oral corticosteroids in addition to study medication
- Parenteral corticosteroids
- Oral syrups or other formulations containing theophylline | [] |
NCT02261727 | 9.3 | Study Outcomes | *9.3 Study Outcomes* | [] |
NCT02261727 | 9.3.1 | Primary Outcome | Number of COPD exacerbations per participant in 48 weeks
Definition of a severe COPD exacerbation – symptomatic deterioration in COPD symptoms (cough, sputum production or dyspnea) requiring treatment with antibiotics, increase in the dose of oral corticosteroids, hospitalisation or a combination of these.
\_\_\_\_\_... | [] |
NCT02261727 | 9.3.2 | Secondary Outcomes | - Time to first severe exacerbation leading to hospitalisation or death
- Quality of Life using the St George's Respiratory Questionnaire
- COPD Assessment Test (CAT), score out of total 40
- Pre-bronchodilator spirometry: FEV1, FVC, FEV1/FVC
- Post-bronchodilator spirometry: FEV1, FVC, FEV1/FVC
 1 is generally accepted world-wide. COPD is a preventable and treatable disease characterised by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in ... | [] |
NCT02261727 | 10.1.2 | Participant Inclusion Criteria | Participants are eligible for INCLUSION in the study if ALL the following criteria are met:
- Current or former smokers (> 10 pack years) or biomass exposure
- 40 80 years of age
- Clinical diagnosis of COPD
- Post-bronchodilator FEV1 < 70% predicted
- Post bronchodilator FEV1/FVC ratio < 70% | [] |
NCT02261727 | 10.1.3 | Participant Exclusion Criteria | - Patients will be EXCLUDED from the study if, in the opinion or knowledge of the responsible clinician any of the following criterion is present:
- Life expectancy of less than 12 months
- Exacerbation or respiratory infection within 4 weeks prior to randomisation
- Patient is taking and requires maintenance oral cort... | [] |
NCT02261727 | 11 | Assessments and Study Visits | [] | |
NCT02261727 | 11.1 | Brief Study Visits Outline | *11.1 Brief Study Visits Outline*
Patients with COPD and considered eligible will undertake a screening visit, two to four weeks before the randomisation visit (Baseline, Week 0). During the four week run-in, all prohibited medications, specifically any theophylline containing medications and ICS will be ceased. LABA,... | [] |
NCT02261727 | 11.2 | Participant Consent | *11.2 Participant Consent*
Prior to any study related procedures being performed informed consent is to be obtained from each participant. | [] |
NCT02261727 | 11.3 | Study Visits | *11.3 Study Visits* | [] |
NCT02261727 | 11.3.1 | Screening Visit | The purposes of the screening evaluation are to identify patients for study enrolment, provide potentially eligible patients with information regarding the study, obtaining the informed consent for participation in this study. Assessment at this visit will include spirometry and gathering information on the type of med... | [] |
NCT02261727 | 11.3.2 | Baseline Visit & Randomisation | At baseline visit the following baseline characteristics and clinical assessments will be made: vital signs, spirometry, CAT score, medical history including bone fracture, medication, demographics, routine pathology, SGRQ. In addition, blood will be collected for the plasma storage (selected sites only), and also for ... | [] |
NCT02261727 | 11.3.3 | 6, 18, 30 and 42-Weeks Phone Visit | Participants will be phoned up in between clinic visits to review the Participants Diary card, vital status and record any Adverse Events. All information will be recorded directly into the eCRF. | [] |
NCT02261727 | 11.3.4 | 12-Weeks Visit | The following assessments will be performed during this visit: spirometry, CAT score, medication, if applicable, blood collection for the theophylline levels in 100 randomly selected participants. Adverse Events will be recorded, Participant's Diary will be reviewed and study
Protocol Num... | [] |
NCT02261727 | 11.3.5 | 24-Weeks and 36-Weeks Visits | The following will be performed during this visit: spirometry, CAT score and medication, if applicable. Adverse Events will be recorded, Participant's Diary will be reviewed and study medication will be dispensed. Accountability for the returned study medication will be performed. | [] |
NCT02261727 | 11.3.6 | 48-Weeks Visit | The following assessments will be performed during this visit: spirometry,CAT score and medication, if applicable, and SGRQ, In addition, blood will be collected for the plasma storage (selected sites only), for the theophylline levels in 100 randomly selected participants. Adverse Events will be recorded and Participa... | [] |
NCT02261727 | 11.3.7 | 50-Weeks Visit | The ACTH stimulation test to be undertaken 2 weeks after completion of 48 weeks' study treatment in 100 randomly selected participants. | [] |
NCT02261727 | 11.4 | Safety Assessments | *11.4 Safety Assessments*
Symptoms attributable to corticosteroid and theophylline toxicity will be sought and specifically recorded at each patient visit. These will be classified as:
Severe – convulsions
Moderate – stomach discomfort, headache, insomnia, palpitations, weight gain, bruising Routine adverse event da... | [] |
NCT02261727 | 11.5 | Losses to Follow-up | *11.5 Losses to Follow-up*
Efforts will be made to follow all randomised subjects for 48 weeks, irrespective of their adherence to the randomised therapy. All losses to follow-up with reason will be reported to the ICC and reviewed by the Steering Committee. | [] |
NCT02261727 | 11.6 | Non-adherence and Deviations from the Protocol | *11.6 Non-adherence and Deviations from the Protocol*
All participants will be strongly encouraged throughout the study to adhere to the randomised therapy. Participants will continue to be followed for all data collection, irrespective of their adherence to the randomised therapy (intent to treat analysis). | [] |
NCT02261727 | 11.7 | Duration of Subject Participation | *11.7 Duration of Subject Participation*
Individual participants will participate in the 48 weeks treatment phase of the study until the earliest of:
- completion of the intervention period at 48 weeks,
- withdrawal of consent, by the participant or
- participant death
All participants will attend all scheduled thre... | [] |
NCT02261727 | 11.8 | Duration of the Study | *11.8 Duration of the Study*
The expected timelines for the study:
June 2014 TASCS first patient randomised December 2016 Recruitment complete (n=1650)
December 2017 TASCS last patient visit Jan – March 2018 Site close out activities
April – May 2018 Statistical analyses and publication preparation | [] |
NCT02261727 | 11.9 | Screening and Recruitment log | *11.9 Screening and Recruitment log*
The screening and randomisation logs are designed to monitor patient recruitment at the individual study centre. | [] |
NCT02261727 | 11.10 | Data Collection | *11.10 Data Collection*
Streamlined data collection instruments and procedures will be used to minimise the work in collaborating centres. The George Institute for Global Health will take responsibility for the randomisation and data management of the study. This includes programming and data management support of the... | [] |
NCT02261727 | 12 | Statistics | [] | |
NCT02261727 | 12.1 | Power Calculations and Statistical Analysis | *12.1 Power Calculations and Statistical Analysis*
All analyses will be performed on an intention to treat basis (ITT). The primary endpoint of this study is the event rate of exacerbations of COPD. Randomisation of 1650 participants (550 in each arm) will provide 80% power (alpha=0.05) to detect a 20% relative risk r... | [] |
NCT02261727 | 12.1.1 | Baseline characteristics | All analyses will be performed on an intention-to-treat basis. Baseline comparability of the intervention and control groups will be assessed via descriptive analyses in terms of age, gender, medical history, etc. Descriptive demographic and baseline clinical characteristics statistics will be used for the total popula... | [] |
NCT02261727 | 12.1.2 | Effects of treatment | For the primary efficacy analysis, the events rate of exacerbations of COPD will be analysed using Negative Binomial regression. Time to first severe exacerbation will be analysed using a Cox models Kaplan-Meier plot. Analysis of other secondary outcomes will be conducted using standard statistical procedures applicabl... | [] |
NCT02261727 | 12.2 | Randomisation and Allocation of Treatment | *12.2 Randomisation and Allocation of Treatment*
Treatment randomisation will be stratified by smoking status and centre. The randomisation process will be centrally administered. . Details of the randomisation schedule will remain confidential and known by a limited number of persons including the unblinded statistic... | [] |
NCT02261727 | 12.3 | Missing Data | *12.3 Missing Data*
Efforts to minimise missing data will be made and will include data monitoring and feedback, the collection of data from individuals after termination of randomised therapy and rescheduling visits if a participant is hospitalised or unavailable. Methods for handling missing data at the analysis sta... | [] |
NCT02261727 | 12.4 | Blinding | *12.4 Blinding*
Key clinical endpoints will be collected in a fashion that will allow bias to be minimised as much as possible. Both, participants and investigators will be fully blinded to the treatment allocation. Similarly, the endpoints will be collected by study personnel unaware of treatment allocation. The only... | [] |
NCT02261727 | 12.5 | Final Analysis | *12.5 Final Analysis*
Enrolment will be terminated when 1650 participants have been randomised into the study. When all participants have completed their 48 weeks assessment the main analysis will be conducted for all endpoints and safety. | [] |
NCT02261727 | 13 | Termination of Study Treatment | Study treatment prior to 48 weeks will cease if or when any of the following criteria are met:
- Participant withdraws consent for study treatment, *or*
- Participant dies, *or*
- The treating clinicians consider it is clearly in the participant's best interest to receive treatment other than the randomised therapy, *... | [] |
NCT02261727 | 14 | Human Research Ethics Committee Approvals | An application requesting approval to conduct this study will be submitted to the Human Research Ethics Committee (HREC) of the University of Sydney (central HREC), followed by the HREC application at each of the participating regional centres or hospitals and/or at a central ethics committee where applicable. Each app... | [] |
NCT02261727 | 15 | Informed Consent | A copy of each participating centre's proposed informed consent document should be submitted to the George Institute for Global Health for review and comment before submission to the relevant ethics committee. The study should not begin until the document has been approved by the ethics committee. Copies of the regulat... | [] |
NCT02261727 | 15.1 | Documentation of Consent | *15.1 Documentation of Consent*
A copy of the signed participant consent and participant information statement will be given to the participant who has provided the informed consent. The original copy of the signed informed consent will be filed in the participant's study related records and kept in a locked room or c... | [] |
NCT02261727 | 15.2 | Withdrawal of Consent | *15.2 Withdrawal of Consent*
At any time during the study, the participant may withdraw consent to participate in the study. This is documented in the informed consent form and participant information statement. | [] |
NCT02261727 | 16 | Other therapies | All participants will receive routine care as delivered in their usual context of clinical care.
Protocol Number: TGI-Resp-01 | [] |
NCT02261727 | 17 | Data Safety Monitoring Committee | An independent Data Safety Monitoring Committee (DSMC), independent from the investigators participating in the study, will perform an ongoing review of predefined safety parameters and overall study conduct. The DSMC will be comprised of experts in clinical trials, bio-statistics and respiratory medicine. The committe... | [] |
NCT02261727 | 18 | Assessment of Safety | The investigator agrees to record all study specific AEs. Furthermore, the investigator is responsible for ensuring that any co-investigator or sub-investigator brings SAEs to the attention of the investigator, and then the investigator notifies the national medical leader according to GCP – i.e. within 24 hours of any... | [] |
NCT02261727 | 18.1 | Definitions | *18.1 Definitions*
The term "adverse event," as used here, is synonymous with the term "adverse experience," which is used by the TGA. | [] |
NCT02261727 | 18.1.1 | Adverse Event | An Adverse Event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a human being participating in a clinical study with a sponsor treatment, regardless of causal relationship.
Protoco... | [] |
NCT02261727 | 18.1.1.1 | Recording of Adverse Events | The collection of study specific adverse events should be limited to:
- i. Weight gain (>5kgs since baseline)
- ii. Fractures
- iii. Pneumonia
- iv. Other infections
- v. A new diagnosis of diabetes or hypertension
- vi. Stomach discomfort
- vii. Epileptic fits | [] |
NCT02261727 | 18.1.2 | Serious Adverse Event | A Serious Adverse Event (SAE) is any AE that meets 1 or more of the following criteria:
- Results in death;
- Is life-threatening;
- Requires in-patient hospitalisation or prolongation of existing hospitalisation;
- Results in persistent or significant disability/incapacity;
- Results in a congenital anomaly/birth def... | [] |
NCT02261727 | 18.1.2.1 | Recording of Serious Adverse events | At each required study visit, all SAEs that have occurred since the previous visit must be recorded. The following SAE information must be included (when applicable): the specific condition or event; the dates and times of occurrence; severity; causal relationship to treatment; action taken; and outcome.
The causal re... | [] |
NCT02261727 | 18.1.3 | Timing for Reporting Serious Adverse Events | All SAEs should be reported using the eCRF within the required timeframe after the site staff becomes aware of the SAE. Compliance with this requirement is essential so that the study team is aware of any safety signals and thus complies with local regulatory obligations. Where applicable all follow-up information rela... | [] |
NCT02261727 | 18.1.4 | Documentation of Adverse Events and Serious Adverse Events | Study specific AEs and all SAEs will be reported on the eCRFs after randomisation. The AEs and SAEs must be documented in the source documents. The study centre investigator has to follow up all SAEs until the event has subsided or values have returned to baseline, or in case of permanent impairment, until the conditio... | [] |
NCT02261727 | 19 | Data Quality Assurance | A qualified representative of the George Institute for Global Health will monitor the conduct of the study by visiting the centre and by contacting the centre by telephone and email. During the visits, information recorded on the CRFs will be verified against source documents. Quality control of spirometry will occur a... | [] |
NCT02261727 | 19.1 | Pre-study Documentation | *19.1 Pre-study Documentation*
The investigator must provide The George Institute for Global Health with the following documents BEFORE enrolling any participants:
- Current signed and dated curricula vitae for the investigator, sub-investigators, and all key personnel listed on the clinical study information form.
-... | [] |
NCT02261727 | 19.2 | Declaration of Helsinki | *19.2 Declaration of Helsinki*
This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice (GCP) and the applicable local regulatory requirements. | [] |
NCT02261727 | 19.3 | Source Data Documentation | *19.3 Source Data Documentation*
The purpose of source documents is to document the existence of the participant and substantiate the integrity of the study data collected. Adequate and accurate source documents allow the investigator and the centre monitor to verify the reliability and authenticity of data recorded o... | [] |
NCT02261727 | 19.4 | Case Report Forms | *19.4 Case Report Forms*
All data will be recorded in the CRFs. Information recorded in the CRF should accurately reflect participant's medical/hospital notes. Information must be completed in the case report form as soon as it is made available for recording. The intent of this process is to improve the quality of th... | [] |
NCT02261727 | 19.5 | Review of Source Records | *19.5 Review of Source Records*
During and after this study qualified representatives of The George Institute for Global Health will conduct inspections, audit and review medical records pertinent to the clinical study as permitted by the regulations. Participants will not be identified by name, and confidentiality of... | [] |
NCT02261727 | 19.6 | Monitoring of the Study | *19.6 Monitoring of the Study*
This study will be monitored by a representative of The George Institute for Global Health. Centre monitoring visits will be performed in regular intervals. Communication by telephone and mail and e-mail may be used as needed to supplement centre visits. The investigator and study person... | [] |
NCT02261727 | 19.7 | Protocol Amendments | *19.7 Protocol Amendments*
Any significant change in the study protocol will require an amendment. The investigator and an appropriate representative of the Steering Committee will indicate their approval by signing the approval page of the amendment. Once the Steering Committee has approved a protocol amendment, the ... | [] |
NCT02261727 | 19.8 | Change in Investigator | *19.8 Change in Investigator*
If any investigator retires, relocates, or otherwise withdraws from conducting a study, the responsibility for maintaining records may be transferred to The George Institute for Global Health, HREC, or other investigator. The George Institute for Global Health must be notified of and agre... | [] |
NCT02261727 | 19.9 | Termination of the Study | *19.9 Termination of the Study* | [] |
NCT02261727 | 19.9.1 | Termination by the Study Steering Committee | The Study Steering Committee may terminate the entire study or terminate the study at a particular centre at any time for any of the following reasons:
- Failure to enroll participants.
- Protocol violations.
- Inaccurate or incomplete data.
- Unsafe or unethical practices.
- Questionable safety of the treatment.
- Su... | [] |
NCT02261727 | 19.9.2 | Termination by the Investigator | If the investigator terminates the study prematurely, the investigator will do the following:
- Return all study materials to The George Institute for Global Health.
- Provide the HREC and The George Institute for Global Health with a written statement describing why the study was terminated prematurely.
\_\_\_\_\_\_... | [] |
NCT02261727 | 19.9.3 | Notification of Study Closure | The investigator completes a report notifying the HREC of the conclusion of the clinical study. This report should be made within 3 months of completion or termination of the study. The final report sent to the HREC is also sent to The George Institute for Global Health. | [] |
NCT02261727 | 20 | Confidentiality | All unpublished information that The Steering Committee forwards to the investigator shall be kept confidential and should not be published or disclosed to a third party without the prior written consent of The Steering Committee. | [] |
NCT02261727 | 21 | Records Retention | The investigator shall retain and preserve one copy of all data generated in the course of the study, specifically including but not limited to those documents defined by GCP as essential documents, for 15 years following study closure. At the end of such period, the investigator shall notify in writing The Internation... | [] |
NCT02261727 | 22 | Organisation and Collaboration | The study will be conducted under the auspices of The George Institute for Global Health, University of Sydney. It will be overseen by the Steering Committee. | [] |
NCT02261727 | 23 | Publications and Presentations | The main reports from the study will be published in the name of "The TASCS Study Investigators" as requested by the publishing journal with credit assigned as determined by the Steering Committee to the appropriate investigators. Presentations of the study findings will be made at national and international meetings.
... | [] |
NCT02261727 | 24 | References | - 1. GOLD, Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease Updated 2011 (GOLD).
- 2. Halbert, R.J., et al., Global burden of COPD: systematic review and meta-analysis. European Respiratory Journal, 2006. 28(3): p. 523-532.
- 3. Buist, A.S., et al., International va... | [] |
NCT02531633 | 1 | PROTOCOL SYNOPSIS FOR STUDY 201677 |
Multiple lines of evidence support a role for interleukin-6 (IL-6) in the pathophysiology of giant cell arteritis (GCA). Sirukumab is a human anti-IL-6 immunoglobulin IgG1kappa monoclonal antibody (mAb) with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in th... | [
"Rationale",
"Objective(s)/Endpoint(s)",
"Overall Design",
"Treatment Arms and Duration",
"Type and Number of Subjects",
"Analysis"
] |
NCT02531633 | 2 | INTRODUCTION | Sirukumab is a human anti-IL-6 immunoglobulin IgG1kappa mAb with a high affinity and specificity for binding to the human IL-6 molecule that is being developed for the treatment of giant cell arteritis (GCA). | [] |
NCT02531633 | 2.1 | Study Rationale | Multiple lines of evidence support a role for IL-6 in the pathophysiology of GCA [[Emilie](#page-99-0), 1994; [Roche](#page-101-0), 1993]. Sirukumab is a human anti-IL-6 immunoglobulin IgG1kappa mAb with a high affinity and specificity for binding to the human IL-6 molecule that may have therapeutic benefit in the trea... | [] |
NCT02531633 | 2.2 | Brief Background | GCA is a systemic vasculitis affecting medium-sized and large arteries usually accompanied or preceded by systemic inflammation. It is the most common primary form of vasculitis in the United States and Europe and occurs predominantly in individuals aged 50 years or over with the mean age of onset of approximately 70 y... | [] |
NCT02531633 | 3 | OBJECTIVE(S) AND ENDPOINT(S) | Part A: 52-week double-blind treatment phase
| Objectives ... | [] |
NCT02531633 | 4 | STUDY DESIGN | [] | |
NCT02531633 | 4.1 | Overall Design | This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 2 doses of sirukumab in the treatment of GCA. The study design is summarized in [Figure 1](#page-25-0). The study will be conducted in 2 distinct parts (Part A and Part B) and consists of the following phase... | [] |
NCT02531633 | 4.2 | Treatment Arms and Duration | [] | |
NCT02531633 | 4.2.1 | Part A: 52-week double-blind treatment phase | Following the Screening period, eligible subjects will be randomized at Baseline into Part A in a ratio of 3:3:2:2:2 to one of five treatment arms:
- 1. Treatment Arm A: Sirukumab 100 mg SC q2w for 52 weeks plus a pre-specified maximum of 6-month prednisone taper regimen(n=51)
- 2. Treatment Arm B: Sirukumab 100 mg SC... | [] |
NCT02531633 | 4.2.2 | Part B: 104-week extension phase | All subjects who complete Part A of the study will be eligible to enter part B. The two populations of subjects expected to enter into Part B are:
- Subjects in remission at the primary 52-week endpoint. These subjects will discontinue blinded study drug treatment on entry into Part B and will be followed for maintena... | [] |
NCT02531633 | 4.3 | Type and Number of Subjects | Approximately 204 subjects with a diagnosis of GCA based on the Revised GCA Diagnosis Criteria will be randomized at Baseline into the 52-week double-blind, placebo controlled phase (Part A) of the study. Eligible subjects will include both GCA patients with new onset disease (diagnosis within 6 weeks of baseline) and ... | [] |
NCT02531633 | 4.4 | Design Justification | There have been limited controlled studies conducted to evaluate therapies for GCA and no successful regulatory precedent for biologic treatment of GCA. The design of this study is similar to the ongoing Phase III study with tocilizumab in GCA subjects [[Unizony](#page-103-0), 2013].
High dose corticosteroid therapy r... | [] |
NCT02531633 | 4.5 | Dose Justification | Two doses of sirukumab (100 mg SC q2w and 50 mg SC q4w) were selected based on doses which have demonstrated efficacy in a Phase II study of rheumatoid arthritis subjects and are presently under investigation in Phase III studies for the treatment of moderate to severe rheumatoid arthritis. The 100 mg SC q2w dose of si... | [] |
NCT02531633 | 4.6 | Benefit:Risk Assessment | Summaries of findings from both clinical and non-clinical studies conducted with sirukumab can be found in the Investigator's Brochure. The following section outlines the risk assessment and mitigation strategy for this protocol: | [] |
NCT02531633 | 4.6.1 | Risk Assessment | | Potential Risk of Clinical Significance | Summary of Data/Rationale for Risk ... | [] |
NCT02531633 | 4.6.2 | Benefit Assessment | The efficacy of sirukumab in subjects with GCA has yet to be established, but available evidence suggests that inhibition of IL-6 activity may be of therapeutic benefit in the treatment of GCA by interruption of multiple pathogenic pathways. IL-6 inhibition results in improvements in patients with active arthritis and ... | [] |
NCT02531633 | 4.6.3 | Overall Benefit:Risk Conclusion | Although the efficacy of sirukumab in subjects with GCA has yet to be established, it has been shown to be effective in Phase III studies in RA. Furthermore other agents that inhibit IL-6 activity have been shown to be efficacious in RA. All subjects will receive therapy with corticosteroids and will receive a high sta... | [] |
NCT02531633 | 5 | SELECTION OF STUDY POPULATION AND WITHDRAWAL CRITERIA | Specific information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the GSK investigational product or other study treatment that may impact subject eligibility is provided in the IB/IB supplement(s).
Deviations from inclusion and exclusion criteria are not allow... | [] |
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