Trial Outcomes & Findings for A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs) (NCT NCT01617005)

Last Updated: 2016-12-01

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

Baseline up to Week 24

Results posted on

2016-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Tocilizumab in Moderate to Severe Active RA Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab in Moderate to Severe Active RA Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Overall Study Pregnancy	1
Overall Study Lack of motivation for treatment	1

Baseline Characteristics

A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab in Moderate to Severe Active RA n=50 Participants Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Age, Continuous	51.9 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 24

Population: All participants enrolled in the study.

Outcome measures

Outcome measures
Measure	Tocilizumab in Moderate to Severe Active RA n=50 Participants Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) AEs	38 participants
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) SAEs	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All participants enrolled in the study.

EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (\>) 1.2 with a DAS28 score less than or equal to (\<=) 3.2; moderate responders had a CFB \>1.2 with a DAS28 score \>3.2 to \<= 5.1 or a change from baseline \>0.6 to \<= 1.2 with a DAS28 score \<= 5.1; non-responders had a CFB \<=0.6 or CFB \>0.6 to \<=1.2 with DAS28 \>5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.

Outcome measures

Outcome measures
Measure	Tocilizumab in Moderate to Severe Active RA n=50 Participants Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria EULAR Good Response	0 participants
Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria EULAR Moderate Response	40 participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: All participants enrolled in the study.

Outcome measures

Outcome measures
Measure	Tocilizumab in Moderate to Severe Active RA n=50 Participants Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Number of Participants Who Discontinued Treatment Due to Lack of Efficacy	0 participants

SECONDARY outcome

Timeframe: Baseline up to Week 24

Population: As none of the participants discontinued treatment due to lack of efficacy, this outcome measure was not estimable.

Outcome measures

Outcome data not reported

Adverse Events

Tocilizumab in Moderate to Severe Active RA

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tocilizumab in Moderate to Severe Active RA n=50 participants at risk Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
Vascular disorders Hypertension	4.0% 2/50 • Baseline up to Week 24
Blood and lymphatic system disorders Pancytopenia	4.0% 2/50 • Baseline up to Week 24
Blood and lymphatic system disorders Neutropenia	30.0% 15/50 • Baseline up to Week 24
Blood and lymphatic system disorders Leukopenia with neutropenia	16.0% 8/50 • Baseline up to Week 24
Blood and lymphatic system disorders Leukopenia	4.0% 2/50 • Baseline up to Week 24
Blood and lymphatic system disorders Leukocytosis	2.0% 1/50 • Baseline up to Week 24
Blood and lymphatic system disorders Thrombocytopenia	4.0% 2/50 • Baseline up to Week 24
Gastrointestinal disorders Gastralgia	2.0% 1/50 • Baseline up to Week 24
Gastrointestinal disorders Abdominal pain	2.0% 1/50 • Baseline up to Week 24
Gastrointestinal disorders Diarrhea	2.0% 1/50 • Baseline up to Week 24
Investigations Hepatic transaminases increased	20.0% 10/50 • Baseline up to Week 24
Infections and infestations Oral herpes simplex	2.0% 1/50 • Baseline up to Week 24
Infections and infestations Bronchopneumonia	2.0% 1/50 • Baseline up to Week 24
Infections and infestations Cellulitis	2.0% 1/50 • Baseline up to Week 24
Infections and infestations Fever	2.0% 1/50 • Baseline up to Week 24
Cardiac disorders Bradycardia	2.0% 1/50 • Baseline up to Week 24
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/50 • Baseline up to Week 24
Musculoskeletal and connective tissue disorders Polyartralgia	2.0% 1/50 • Baseline up to Week 24
Metabolism and nutrition disorders Hypercholesterolemia with hypertriglyceridemia	2.0% 1/50 • Baseline up to Week 24
Metabolism and nutrition disorders Hypercholesterolemia	18.0% 9/50 • Baseline up to Week 24

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER