NCT01326962 is a Phase 3 clinical trial of tocilizumab [RoActemra/Actemra] in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01326962?

NCT01326962 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01326962?

Interventions in NCT01326962: tocilizumab [RoActemra/Actemra].

What condition does NCT01326962 study?

NCT01326962 studies Rheumatoid Arthritis.

Is NCT01326962 still recruiting?

NCT01326962 is currently completed. Last updated 16 August 2017.

Are results published for NCT01326962?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-16 · How we verify

NCT01326962

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

Completed Phase 3 Results posted Last updated 16 August 2017

What this trial tests

Phase 3 trial testing tocilizumab [RoActemra/Actemra] in Rheumatoid Arthritis in 28 participants. Completed in 12 May 2013.

Timeline

30 November 2011

Primary endpoint
12 May 2013

12 May 2013

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	30 November 2011
Primary completion	12 May 2013
Estimated completion	12 May 2013
Sites	4 locations across Saudi Arabia

Drugs / interventions tested

tocilizumab [RoActemra/Actemra] — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Disease Activity as Measured by Disease Activity Score 28 (DAS28) Primary · Up to 1 year

The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]), and general health status (participant global assessment of disease activity using visual analog scale \[VAS\], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Baseline (n=28)

Group	Value	95% CI
Tocilizumab	5.4	4.1 – 7.9

Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	3.5	1.9 – 5.7

Visit 4 (n= 26)

Group	Value	95% CI
Tocilizumab	2.8	0.9 – 5.5

Visit 5 (n= 25)

Group	Value	95% CI
Tocilizumab	2.2	1.3 – 4.2

Visit 6 (n= 25)

Group	Value	95% CI
Tocilizumab	1.9	0.4 – 4.6

Visit 7 (n= 25)

Group	Value	95% CI
Tocilizumab	1.7	0.5 – 2.8

Visit 8 (n= 23)

Group	Value	95% CI
Tocilizumab	1.7	0.5 – 3.4

Visit 9 (n= 21)

Group	Value	95% CI
Tocilizumab	1.9	0.0 – 3.7

Number of Participants Who Achieved Remission (DAS28 < 2.6) Primary · Up to 1 year

The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	3

Visit 4 (n=26)

Group	Value	95% CI
Tocilizumab	7

Visit 5 (n=25)

Group	Value	95% CI
Tocilizumab	12

Visit 6 (n=25)

Group	Value	95% CI
Tocilizumab	14

Visit 7 (n=25)

Group	Value	95% CI
Tocilizumab	17

Visit 8 (n=23)

Group	Value	95% CI
Tocilizumab	16

Visit 9 (n=21)

Group	Value	95% CI
Tocilizumab	15

Visit 10 (n=22)

Group	Value	95% CI
Tocilizumab	18

Time to Das28 Remission Primary · Up to 1 year

Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score \< 2.6 units. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent h

Group	Value	95% CI
Tocilizumab	189.01	± 7.053

Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units) Primary · Up to 1 year

DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease ac

Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	21

Visit 4 (n=26)

Group	Value	95% CI
Tocilizumab	20

Visit 5 (n=25)

Group	Value	95% CI
Tocilizumab	20

Visit 6 (n=25)

Group	Value	95% CI
Tocilizumab	22

Visit 7 (n=25)

Group	Value	95% CI
Tocilizumab	21

Visit 8 (n=23)

Group	Value	95% CI
Tocilizumab	20

Visit 9 (n=21)

Group	Value	95% CI
Tocilizumab	19

Visit 10 (n=22)

Group	Value	95% CI
Tocilizumab	20

Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2) Primary · Up to 1 year

DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	7

Visit 4 (n=26)

Group	Value	95% CI
Tocilizumab	9

Visit 5 (n= 25)

Group	Value	95% CI
Tocilizumab	7

Visit 6 (n=25)

Group	Value	95% CI
Tocilizumab	7

Visit 7 (n=25)

Group	Value	95% CI
Tocilizumab	4

Visit 8 (n= 23)

Group	Value	95% CI
Tocilizumab	3

Visit 9 (n=21)

Group	Value	95% CI
Tocilizumab	3

Visit 10 (n=22)

Group	Value	95% CI
Tocilizumab	2

Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response Primary · Up to 1 year

Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains. The HAQ is the sum of the scores, divided by the numb

Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	7

Visit 4 (n=25)

Group	Value	95% CI
Tocilizumab	6

Visit 5 (n= 25)

Group	Value	95% CI
Tocilizumab	6

Visit 6 (n=25)

Group	Value	95% CI
Tocilizumab	7

Visit 7 (n=25)

Group	Value	95% CI
Tocilizumab	6

Visit 8 (n= 23)

Group	Value	95% CI
Tocilizumab	4

Visit 9 (n=21)

Group	Value	95% CI
Tocilizumab	5

Visit 10 (n=22)

Group	Value	95% CI
Tocilizumab	4

Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score Primary · Up to 1 year

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 participants 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 f

Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	23.5

Visit 4 (n=26)

Group	Value	95% CI
Tocilizumab	24.1

Visit 5 (n= 25)

Group	Value	95% CI
Tocilizumab	23.6

Visit 6 (n=25)

Group	Value	95% CI
Tocilizumab	24.0

Visit 7 (n=25)

Group	Value	95% CI
Tocilizumab	21.6

Visit 8 (n= 23)

Group	Value	95% CI
Tocilizumab	22.0

Visit 9 (n=21)

Group	Value	95% CI
Tocilizumab	19.1

Visit 10 (n=22)

Group	Value	95% CI
Tocilizumab	22.3

Change in Fatigue as Measured Using the Fatigue Visual Analog Scale Primary · Up to 1 year

The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.

Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	38.1

Visit 4 (n=26)

Group	Value	95% CI
Tocilizumab	32.3

Visit 5 (n= 25)

Group	Value	95% CI
Tocilizumab	29.0

Visit 6 (n=25)

Group	Value	95% CI
Tocilizumab	20.1

Visit 7 (n=25)

Group	Value	95% CI
Tocilizumab	14.4

Visit 8 (n= 23)

Group	Value	95% CI
Tocilizumab	18.0

Visit 9 (n=21)

Group	Value	95% CI
Tocilizumab	13.1

Visit 10 (n=22)

Group	Value	95% CI
Tocilizumab	20.7

Number of Participants With Any Adverse Event and Serious Adverse Event Secondary · Up to 1 year

An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.

Any AE

Group	Value	95% CI
Tocilizumab	4

Any SAE

Group	Value	95% CI
Tocilizumab	2

Number of Participants With AE or SAE Related Discontinuation of Tocilizumab Secondary · Up to 1 year

It included participants who discontinued from the study due to occurrence of AE or SAE.

Group	Value	95% CI
Tocilizumab	2

Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response Secondary · Up to 1 year

ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints). It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (H

ACR20: Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	3

ACR20: Visit 4 (n=26)

Group	Value	95% CI
Tocilizumab	4

ACR20:Visit 5 (n=25)

Group	Value	95% CI
Tocilizumab	1

ACR20: Visit 6 (n=25)

Group	Value	95% CI
Tocilizumab	1

ACR20: Visit 7 (n=25)

Group	Value	95% CI
Tocilizumab	0

ACR20: Visit 8 (n=23)

Group	Value	95% CI
Tocilizumab	0

ACR20: Visit 9 (n=21)

Group	Value	95% CI
Tocilizumab	0

ACR20: Visit 10 (n=22)

Group	Value	95% CI
Tocilizumab	0

Number of Participants With C-Reactive Protein Abnormality Secondary · Up to 1 year

CRP is a biological marker of inflammation. A reduction in CRP indicates improvement. It is measured in milligram per liter (mg/L).

Baseline (n=28)

Group	Value	95% CI
Tocilizumab	16

Visit 3 (n=27)

Group	Value	95% CI
Tocilizumab	8

Visit 4 (n=26)

Group	Value	95% CI
Tocilizumab	7

Visit 5 (n=25)

Group	Value	95% CI
Tocilizumab	2

Visit 6 (n=25)

Group	Value	95% CI
Tocilizumab	5

Visit 7 (n=25)

Group	Value	95% CI
Tocilizumab	6

Visit 8 (n=23)

Group	Value	95% CI
Tocilizumab	7

Visit 9 (n=21)

Group	Value	95% CI
Tocilizumab	7

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 Year. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tocilizumab

Serious: 2/28 (7%)

Deaths: —

Serious adverse events (4 terms)

Reaction	System	Tocilizumab
Hypotension	Vascular disorders	—
Skin Rash	Skin and subcutaneous tissue disorders	—
Neutropenia	Blood and lymphatic system disorders	—
Thrombocytpenia	Blood and lymphatic system disorders	—

Other adverse events (16 terms — click to expand)

Reaction	System	Tocilizumab
Hypertension	Vascular disorders	—
Neutropenia	Blood and lymphatic system disorders	—
Low hemoglobin	Blood and lymphatic system disorders	—
Low red blood cells	Blood and lymphatic system disorders	—
Epistaxis	Blood and lymphatic system disorders	—
Urinary tract infection	Infections and infestations	—
Diplopia	Eye disorders	—
Dry eye	Eye disorders	—
Infusion site pain	General disorders	—
Headache & dizziness	General disorders	—
Headache & generalized body ache	General disorders	—
Fibromyalgia	Musculoskeletal and connective tissue disorders	—
Low back pain	Musculoskeletal and connective tissue disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Flu	Respiratory, thoracic and mediastinal disorders	—
Hyponatremia	Metabolism and nutrition disorders	—

Most-reported serious reactions: Hypotension, Skin Rash, Neutropenia, Thrombocytpenia.

Data from ClinicalTrials.gov NCT01326962 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Biologics or tofacitinib for people with rheumatoid arthritis naive to methotrexate: a systematic review and network meta-analysis.
Singh JA, Hossain A, Mudano AS, Tanjong Ghogomu E, et al · · 2017 · cited 44× · PMID 28481462 · DOI 10.1002/14651858.cd012657
Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis.
Singh JA, Hossain A, Tanjong Ghogomu E, Mudano AS, et al · · 2017 · cited 38× · PMID 28282491 · DOI 10.1002/14651858.cd012591
Tocilizumab efficacy and safety in rheumatoid arthritis patients after inadequate response to disease-modifying anti-rheumatic drugs oranti-tumor necrosis factor.
Abdulkader OAF, Qushmaq K, Aljishi F. · · 2016 · cited 3× · PMID 27236390 · DOI 10.5144/0256-4947.2016.190

Verify or expand the search:

Other trials of tocilizumab [RoActemra/Actemra]

Trials testing the same drug.

NCT01063062 — A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid · Phase 3 · completed
NCT00996203 — A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Respon · Phase 4 · completed
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NCT00848120 — A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis · Phase 3 · completed
NCT00810277 — A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMA · Phase 3 · completed

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

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Other Hoffmann-La Roche trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01326962 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 16 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01326962.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01326962

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of tocilizumab [RoActemra/Actemra]

Other recruiting trials for Rheumatoid Arthritis

Other Hoffmann-La Roche trials

Verify against primary sources