Clinical trial NCT01326962: A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF
Official title: Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-03-31
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Active moderate to severe rheumatoid arthritis of \>/= 6 months duration
* \>/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for \>/=8 weeks at any time prior to study treatment
* Inadequate clinical response to non-biologic DMARD or anti-TNF therapy
* Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug

Exclusion Criteria:

* Pregnant or lactating women
* Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment
* Rheumatic autoimmune disease other than RA
* Functional class IV (ACR classification)
* Prior history of or current joint disease other than RA
* Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* Previous treatment with RoActemra/Actemra
* Known active current or history of recurrent infection
* History of or currently active primary or secondary immunodeficiency
* Active tuberculosis requiring treatment within the previous 3 years
* Positive for HIV

Primary outcomes:
measure: Disease Activity as Measured by Disease Activity Score 28 (DAS28)
timeFrame: Up to 1 year
measure: Number of Participants Who Achieved Remission (DAS28 < 2.6)
timeFrame: Up to 1 year
measure: Time to Das28 Remission
timeFrame: Up to 1 year
measure: Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
timeFrame: Up to 1 year
measure: Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
timeFrame: Up to 1 year
measure: Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
timeFrame: Up to 1 year
measure: Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
timeFrame: Up to 1 year
measure: Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of Participants With Any Adverse Event and Serious Adverse Event
timeFrame: Up to 1 year
measure: Number of Participants With AE or SAE Related Discontinuation of Tocilizumab
timeFrame: Up to 1 year
measure: Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
timeFrame: Up to 1 year
measure: Number of Participants With C-Reactive Protein Abnormality
timeFrame: Up to 1 year
measure: Number of Participants With Erythrocyte Sedimentation Rate Abnormality
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: King Fahad Specialist Hospital; Oncology
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
city: Makkah
country: Saudi Arabia
facility: Heraa General Hospital; Rheumatology
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City; Gastroentrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Abdulkader OAF, Qushmaq K, Aljishi F. Tocilizumab efficacy and safety in rheumatoid arthritis patients after inadequate response to disease-modifying anti-rheumatic drugs oranti-tumor necrosis factor. Ann Saudi Med. 2016 May-Jun;36(3):190-6. doi: 10.5144/0256-4947.2016.190.