Clinical trial NCT01669902: An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
Official title: HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-21
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with active moderate to severe rheumatoid arthritis unable to use methotrexate

Brief summary: This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included
* Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed

Exclusion Criteria:

* Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Percentage of Participants on Tocilizumab Treatment at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of Participants With Dose Modifications of Tocilizumab
timeFrame: Baseline to Month 6
measure: Swollen Joint Count (SJC)
timeFrame: Baseline, Month 3, Month 6
measure: Tender Joint Count (TJC)
timeFrame: Baseline, Month 3, Month 6
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)
timeFrame: Month 3 and Month 6
measure: Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)
timeFrame: Month 3 and Month 6
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
timeFrame: Month 3 and Month 6
measure: Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
timeFrame: Month 3 and Month 6
measure: Simplified Disease Activity Index (SDAI)
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants Achieving Clinical Remission Based on SDAI
timeFrame: Month 3 and Month 6
measure: Clinical Disease Activity Index (CDAI)
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants Achieving Clinical Remission Based on CDAI
timeFrame: Month 3 and Month 6
measure: Number of Participants With an American College of Rheumatology (ACR) Response
timeFrame: Baseline to Month 6
measure: Patient Global Assessment (PtGA) of Disease Activity Score
timeFrame: Baseline, Month 3, Month 6
measure: Physician Global Assessment (PGA) of Disease Activity
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants in a PGA of Disease Activity Score Category
timeFrame: Baseline, Month 3, Month 6
measure: Patient Global Assessment of Pain
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants With Morning Stiffness
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of Participants With Duration of Morning Stiffness
timeFrame: Baseline, Month 3, Month 6
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6
timeFrame: Baseline, Month 3 and Month 6
measure: Percentage of Participants With Concomitant Corticosteroids Treatment
timeFrame: Baseline to Month 6
measure: Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study
timeFrame: Baseline to Month 6
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
city: Holbæk
country: Denmark
city: Kolding
country: Denmark
city: Køge
country: Denmark
city: Svendborg
country: Denmark
city: Vejle
country: Denmark
city: Bergen
country: Norway
city: Gjettum
country: Norway
city: Moss
country: Norway
city: Skien
country: Norway
city: Trondheim
country: Norway
city: Falun
country: Sweden
city: Farsta
country: Sweden
city: Goteborg
country: Sweden
city: Helsingborg
country: Sweden
city: Hudiksvall
country: Sweden
city: Jönköping
country: Sweden
city: Karlskrona
country: Sweden
city: Karlstad
country: Sweden
city: Kristianstad
country: Sweden
city: Malmo
country: Sweden
city: Simrishamn
country: Sweden
city: Skoevde
country: Sweden
city: Trelleborg
country: Sweden
city: Uppsala
country: Sweden
city: Västerås
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: