A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01668966
• Date of registration: 16/08/2012
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
• Scientific title: A Multicenter, Open-Label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis
• Date of first enrolment: December 9, 2013
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01668966
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Brazil

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants who completed their last WA19926 (NCT01649804) core study visit (Week
104) and who may benefit from study drug treatment according to the Investigator's
assessment

- No current or recent adverse event or laboratory finding preventing the use of
tocilizumab 8 mg/kg at baseline visit

- Women of childbearing potential must agree to use highly reliable contraception during
the treatment period

Exclusion Criteria:

- Pregnant or breastfeeding females

- Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study
for any reason

- Treatment with any investigational agent or cell-depleting therapies since the last
administration of study drug in WA19926 (NCT01649804)

- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,
or a T-cell costimulation modulator since the last administration of study drug in
WA19926 (NCT01649804)

- Immunization with a live/attenuated vaccine since the last administration of study
drug in WA19926 (NCT01649804)

- Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune
disease other than RA

- Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint
disease other than RA

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies, including tocilizumab and its excipients

- Evidence of severe uncontrolled concomitant disease or disorder

- Known active infections or history of recurrent infections

- Active tuberculosis requiring treatment in the previous 3 years

- History of alcohol, drug or chemical abuse since inclusion in the WA19926
(NCT01649804) study



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tocilizumab

Primary Outcome(s)

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to approximately 104 weeks]

Percentage of Participants With TEAEs of Special Interest [Time Frame: Baseline up to approximately 104 weeks]

Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation [Time Frame: Baseline up to approximately 104 weeks]

Secondary Outcome(s)

CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points [Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)]

CFB in Swollen Joint Count (SJC) at Specified Time Points [Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)]

CFB in Tender Joint Count (TJC) at Specified Time Points [Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)]

CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points [Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)]

Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [ [Time Frame: Baseline up to approximately 104 weeks]

CFB in PGA of Pain Using VAS Score at Specified Time Points [Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)]

Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points [Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)]

Time to RA Crisis Among Participants Who Discontinued After Clinical Remission [Time Frame: Baseline up to approximately 104 weeks]

CFB in PGA of Disease Activity Using VAS Score at Specified Time Points [Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)]

CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points [Time Frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)]

Secondary ID(s)

ML28080

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01668966