ActUp

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
RS Cipto Mangunkusumo, Jakarta; RS Pantai Indah Kapuk, Jakarta; RS Hasan Sadikin, Bandung; RS Saiful Anwar, Malang; RS Kariadi, Semarang; RS Boloni, Medan; RS Restu Ibu, Balikpapan; RS Sanglah, Bali
No Registry
INA-4Q9Y8KM
Tanggal Input Registry : 28-09-2017

22-02-2017
To observe in routine clinical practice the patterns of usage of tocilizumab in patients suffering from RA with regard to persistence on drug and adherence to the licensed label recommendations.
1. To observe the rates and reasons for tocilizumab dose modifications: - Dose increase or decrease. - Dosing Frequency modifications - Dose interruption. - Dose discontinuation. - Reintroduction. - Adherence of physicians to the recommended dosing regimen and the reasons for deviations. 2. To observe the demographic and RA disease characteristics at the time of initiating tocilizumab, including the following: -Prevalence of extra-articular (systemic) features of RA. -The differences in patient characteristics when the drug is used: > after DMARDs intolerance and/or IR. > After IR to other biologics (primary or secondary failures). - Rationale for tocilizumab to be used as monotherapy as opposed to its combination with DMARDs. - The management of dosing in case of safety concerns (adherence to guidelines in the package insert). 3. To observe treatment efficacy and safety in clinical practice: - Efficacy measures based on total joint count evaluation (28 or 66/68 joint count): such as disease activity score based on 28 joint count (DAS28) score, EULAR response, Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) scores, and ACR response. - To observe the patterns of efficacy according to: > tocilizumab monotherapy versus combination, dose modification. > patient sub-types (e.g., presence of systemic signs and symptoms such as anemia and fatigue). - To observe the reasons for and time to DMARD and steroid dose reductions/withdrawal. - Diagnostic tools used to diagnose and monitor infections: signs and symptoms, acute phase reactants (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]), white blood cells, procalcitonin, etc. - To observe the patterns of laboratory and clinical parameters prior to and during infective AEs and serious adverse events (SAEs).
 
ActUp
A phase IV, multi-center, non-interventional study in rheumatoid arthritis (RA) patients treated with tocilizumab
Observasional
This is a 6-month non-interventional, observational, post-marketing, multi-center and local study in RA patients, who are currently being treated with tocilizumab. This study is observational therefore no additional visits will be required, no study-specific medication will be administered and no other interventional procedures additional to those comprising routine clinical practice will be performed. The co-morbidities of patients meeting all selection criteria will be reviewed and patients will be followed-up over a 6-month observation period. Since patients have initiated treatment prior to study start-up, data collection is partially retrospective. Data collection will include the following sources: - Patients’ co-morbidities. - Data recorded by the principal investigator and collaborators during the routine visits of the patient. Since the study is observational, the visits are those pre-scheduled as part of usual clinical practice. These include: - One enrolment visit (this visit may occur up to 8 weeks after the first tocilizumab treatment, and in this case data collection will be retrospectively collected up to the first tocilizumab treatment). - Usual follow-up visits according to the center’s practice, which will take place during the study observation period up to 6 months after tocilizumab treatment initiation. - One final visit, corresponding to that performed nearest to 6 months after tocilizumab treatment initiation. Additional tests for the recruited patients are not foreseen, since this is an observational study. The doses and duration of treatment will be stipulated by the Investigator, according to local guidelines and/or routine clinical practice. No study-specific drug will be administered. The dose and duration of treatment before, during, and after the study will be based upon the Investigator’s judgment and in accordance with the label and local regulations. Tocilizumab administration may occur as per routine practice and following the local label. Treatment-related information (including efficacy and safety information, where available) may be collected at the same time-points as tocilizimab administration, but will be at the discretion of the investigator in line with local routine practice. The study population will include patients with moderate to severe RA, according to ACR criteria [13] and DAS28 joint scores [43], in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label). This can include patients who have received tocilizumab treatment within 8 weeks prior to the enrollment visit. Furthermore, patients must have given their informed consent and must not meet any of the exclusion criteria
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Inclusion Criteria:

Inclusion Criteria A patient may be included if the answer to all of the following statements is “yes”: 1. At least 18 years of age. 2. Diagnosis of moderate to severe RA according to the revised (1987) ACR criteria [13]. 3. Patient in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label: DMARD-IR,TNF-IR or need tocilizumab monotherapy). This can include patients who have received tocilizumab treatment within 8 weeks prior to the enrolment visit. 4. Has been given oral and written information about the study and has no objection to the data concerning him/her being subject to computerized data processing (i.e., has given informed consent).

Exclusion Criteria:

Exclusion Criteria A patient will be excluded if the answer to any of the following statements is “yes”: 1. Has received tocilizumab more than 8 weeks prior to the enrolment visit. 2. Has previously received tocilizumab in a clinical trial or for compassionate use. 3. Has been enrolled in an ongoing clinical trial and/or has received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with tocilizumab. 4. Has a history of autoimmune disease or of any joint inflammatory disease other than RA.
 
Komite Etik Fakultas Kedokteran Universitas Indonesia, 17/PT 02.FK/ETIK/2012, 16 Jan 2012
NA
PN.01.07.313.3.02.12.475, 15 Feb 2012
ML28216
Prof. Dr. Harry Isbagio, SpPD-KR; Dr. Bambang Setyohadi SpPD-KR; Dr. Rudy Hidayat, SpPD-KR; Dr. Rachmat Gunadi, SpPD-KR; Prof. DR. Handono Kalim, SpPD-KR; Dr. Bantar Suntoko, SpPD-KR; Dr. Blondina Marpaung, SpPD-KR; Dr. Natsir Akil, SpPD-KR; Dr. I Gede Kambayana, SpPD-KR