Rheumatoid ArthritisPhase 4NCT01149057

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS

A Phase 4 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 16 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: tocilizumab [RoActemra/Actemra]
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 16 sitesIsrael
Study dates: Oct 2010to Jul 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients, >/=18 years of age
Active moderate to severe rheumatoid arthritis
Inadequate response to >/=3 DMARDs (non-biologic and/or biologic)
Current treatment at stable dose for >/=8 weeks
Etanercept discontinued >/=2 weeks, Anakinra >/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab >/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab >/=16 weeks, and must have proven B-cell repletion

Who cannot join

Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
Rheumatic autoimmune disease other than RA
Functional class IV (American College of Rheumatology Classification)
Prior history or current inflammatory joint disease other than RA
Oral corticosteroids at a dose of >10 mg/day prednisone equivalent
Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody
Current or history of recurrent bacterial, viral, fungal or mycobaterial infection
History of or currently active primary or secondary immunodeficiency

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Israel16 sites

Study site
Afula, 18101
Study site
Ashkelon, 78306
Study site
Beer Yaakov, 6093000
Study site
Beersheba, 8410101
Study site
Hadera, 38100
Study site
Haifa, 3109601
Study site
Haifa, 3339419
Study site
Haifa, 34362
Study site
Holon, 58100
Study site
Jerusalem, 9112001
Study site
Jerusalem, 91240
Study site
Kfar Saba, 44281
Study site
Petah Tikva, 4941492
Study site
Ramat Gan, 5262000
Study site
Rehovot, 76100
Study site
Tel Aviv, 6423906

Other trials in Israel

About this study

Official title: An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs

Conditions: Rheumatoid Arthritis
Being tested: tocilizumab [RoActemra/Actemra]
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tocilizumab [RoActemra/Actemra]Drug
8 mg/kg intravenously, every 4 weeks for 96 weeks

Study groups in NCT01149057
Study group	Role	What they receive
Single Arm	Experimental	Not described Receives: Drug: tocilizumab [RoActemra/Actemra]

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Measured: Baseline, Week 24
Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Measured: Baseline, Week 48
Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Measured: Baseline, Week 72
Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Measured: Baseline, Week 96
Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Measured: Baseline, Week 24
Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Measured: Baseline, Week 48
Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Measured: Baseline, Week 72
Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Measured: Baseline, Week 96

Secondary outcomes (14)

Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study
BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation [SD] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated.
Measured: Baseline, End of the study (up to Week 100)
Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96
Remission was defined as DAS28 score less than (<) 2.6. The DAS28 score was a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity (visual analog scale [VAS]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity.
Measured: Weeks 24, 48, 72 and 96
Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96
Remission was defined as DAS28 score <2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity.
Measured: Weeks 24, 48, 72 and 96
Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96
The DAS28 score was a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline <-1.2. EULAR Moderate response: DAS28 greater than (>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline <-0.6 to greater than or equal to (≥) -1.2.
Measured: Weeks 24, 48, 72 and 96
Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96
SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter [cm]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0.
Measured: Weeks 24, 48, 72 and 96
Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96
CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0.
Measured: Weeks 24, 48, 72 and 96
Change From Baseline in TJC At Weeks 24, 48, 72, and 96
68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from baseline indicated improvement.
Measured: Baseline; Weeks 24, 48, 72 and 96
Change From Baseline in SJC At Weeks 24, 48, 72, and 96
66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from baseline indicated improvement.
Measured: Baseline; Weeks 24, 48, 72 and 96
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96
ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria.
Measured: Weeks 24, 48, 72 and 96
Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96
Measured: Baseline; Weeks 20, 44, 72 and 96
C-reactive Protein Level
Measured: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Erythrocyte Sedimentation Rate
Measured: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Participant Assessment of Pain (VAS)
The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated "No pain," and the right endpoint (100) indicated "Unbearable pain". Higher score indicated higher pain.
Measured: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96
HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Measured: Baseline; Weeks 24, 48, 72 and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Jul 2014

First posted23 Jun 2010 (estimated)
Study startOct 2010
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01149057
Sponsor's protocol ID: ML22873
Status last verified: Nov 2016
First submitted: 22 Jun 2010
Last updated: 2 Nov 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs
ClinicalTrials.gov ID: NCT01149057
Acronym / sponsor ID: ML22873
Conditions: Rheumatoid Arthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Collaborators: Clalit Health Services
Study start: Oct 2010
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 23 Jun 2010 (estimated)
Results: Posted 29 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Drug: tocilizumab [RoActemra/Actemra]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult patients, >/=18 years of age
Active moderate to severe rheumatoid arthritis
Inadequate response to >/=3 DMARDs (non-biologic and/or biologic)
Current treatment at stable dose for >/=8 weeks
Etanercept discontinued >/=2 weeks, Anakinra >/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab >/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab >/=16 weeks, and must have proven B-cell repletion

Key exclusion criteria (8 listed)

Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
Rheumatic autoimmune disease other than RA
Functional class IV (American College of Rheumatology Classification)
Prior history or current inflammatory joint disease other than RA
Oral corticosteroids at a dose of >10 mg/day prednisone equivalent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tocilizumab [RoActemra/Actemra]8 mg/kg intravenously, every 4 weeks for 96 weeks	Drug	Single Arm

Primary outcome

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population
Time frame: Baseline, Week 24
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population
Time frame: Baseline, Week 48
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population
Time frame: Baseline, Week 72
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population
Time frame: Baseline, Week 96
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population
Time frame: Baseline, Week 24
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population
Time frame: Baseline, Week 48
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population
Time frame: Baseline, Week 72
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population
Time frame: Baseline, Week 96
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).

14 secondary outcomes

Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study
Time frame: Baseline, End of the study (up to Week 100)
Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96
Time frame: Weeks 24, 48, 72 and 96
Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96
Time frame: Weeks 24, 48, 72 and 96
Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96
Time frame: Weeks 24, 48, 72 and 96
Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96
Time frame: Weeks 24, 48, 72 and 96
Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96
Time frame: Weeks 24, 48, 72 and 96
Change From Baseline in TJC At Weeks 24, 48, 72, and 96
Time frame: Baseline; Weeks 24, 48, 72 and 96
Change From Baseline in SJC At Weeks 24, 48, 72, and 96
Time frame: Baseline; Weeks 24, 48, 72 and 96
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96
Time frame: Weeks 24, 48, 72 and 96
Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96
Time frame: Baseline; Weeks 20, 44, 72 and 96
C-reactive Protein Level
Time frame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Erythrocyte Sedimentation Rate
Time frame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Participant Assessment of Pain (VAS)
Time frame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96
Time frame: Baseline; Weeks 24, 48, 72 and 96

Results and safety

Results posted to the registry on 29 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tocilizumab	145	88

Primary outcome: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population

Time frame: Baseline, Week 24. Mean (Standard Deviation). Unit: units on a scale

Measure	Tocilizumab n = 142
Baseline (n=142)	21.2 (11.8)
Change From Baseline at Week 24 (n=118)	5.4 (9.6)

Tocilizumab: p <0.0001, Paired sample T-test

Population analysed: ITT population. Number of participants analysed=participants with available data for this endpoint. Here, 'n' signifies participants with available data at specified time point.

Primary outcome: Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population

Time frame: Baseline, Week 48. Mean (Standard Deviation). Unit: units on a scale

Measure	Tocilizumab n = 97
Value	6.7 (10.5)

Tocilizumab: p <0.0001, Paired sample T-test

Population analysed: ITT population. Number of participants analyzed=participants with available data at specified time point.

Primary outcome: Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population

Time frame: Baseline, Week 72. Mean (Standard Deviation). Unit: units on a scale

Measure	Tocilizumab n = 75
Value	7.1 (10.7)

Tocilizumab: p <0.0001, Paired sample T-test

Population analysed: ITT population. Number of participants analyzed=participants with available data at specified time point.

Primary outcome: Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population

Time frame: Baseline, Week 96. Mean (Standard Deviation). Unit: units on a scale

Measure	Tocilizumab n = 83
Value	7.3 (10.4)

Tocilizumab: p <0.0001, Paired sample T-test

Population analysed: ITT population. Number of participants analyzed=participants with available data at specified time point.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to 4 weeks after last dose of the study medication (up to Week 100). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tocilizumab	36 of 145 (24.8%)	134 of 145 (92.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 16 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population (time frame: Baseline, Week 24). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01149057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.