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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT01669902
Date of registration:	13/08/2012
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
Scientific title:	HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD
Date of first enrolment:	April 2012
Target sample size:	107
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01669902
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Denmark	Norway	Sweden	United States

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Primary Outcome(s)

Percentage of Participants on Tocilizumab Treatment at Month 6 [Time Frame: Month 6]

Secondary Outcome(s)

Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP) [Time Frame: Month 3 and Month 6]

Percentage of Participants Achieving Clinical Remission Based on SDAI [Time Frame: Month 3 and Month 6]

Patient Global Assessment (PtGA) of Disease Activity Score [Time Frame: Baseline, Month 3, Month 6]

Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP) [Time Frame: Month 3 and Month 6]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6 [Time Frame: Baseline, Month 3 and Month 6]

Simplified Disease Activity Index (SDAI) [Time Frame: Baseline, Month 3, Month 6]

Tender Joint Count (TJC) [Time Frame: Baseline, Month 3, Month 6]

Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study [Time Frame: Baseline to Month 6]

Clinical Disease Activity Index (CDAI) [Time Frame: Baseline, Month 3, Month 6]

Percentage of Participants in a PGA of Disease Activity Score Category [Time Frame: Baseline, Month 3, Month 6]

Percentage of Participants With Concomitant Corticosteroids Treatment [Time Frame: Baseline to Month 6]

Percentage of Participants With Duration of Morning Stiffness [Time Frame: Baseline, Month 3, Month 6]

Percentage of Participants With Morning Stiffness [Time Frame: Baseline, Month 3, Month 6]

Percentage of Participants Achieving Clinical Remission Based on CDAI [Time Frame: Month 3 and Month 6]

Patient Global Assessment of Pain [Time Frame: Baseline, Month 3, Month 6]

Percentage of Participants With Dose Modifications of Tocilizumab [Time Frame: Baseline to Month 6]

Percentage of Participants With EULAR Response Based on DAS28-4 (ESR) [Time Frame: Month 3 and Month 6]

Swollen Joint Count (SJC) [Time Frame: Baseline, Month 3, Month 6]

Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [Time Frame: Baseline, Month 3, Month 6]

Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [Time Frame: Baseline, Month 3, Month 6]

Number of Participants With an American College of Rheumatology (ACR) Response [Time Frame: Baseline to Month 6]

Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR) [Time Frame: Month 3 and Month 6]

Physician Global Assessment (PGA) of Disease Activity [Time Frame: Baseline, Month 3, Month 6]

Secondary ID(s)

ML28247

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	23/11/2015
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT01669902

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