NCT00673920 (FEATURE) is a Phase 3 clinical trial of Methotrexate in Rheumatoid Arthritis, sponsored by Genentech, Inc..

Who is sponsoring NCT00673920?

NCT00673920 is sponsored by Genentech, Inc..

What drugs are being tested in NCT00673920?

Interventions in NCT00673920: Methotrexate, Ocrelizumab, Placebo.

What condition does NCT00673920 study?

NCT00673920 studies Rheumatoid Arthritis.

Is NCT00673920 still recruiting?

NCT00673920 is currently terminated. Last updated 4 December 2020.

Are results published for NCT00673920?

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

Last reviewed 2020-12-04 · How we verify

NCT00673920: FEATURE

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

A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

Terminated Phase 3 Results posted Last updated 4 December 2020

What this trial tests

Phase 3 trial testing Methotrexate in Rheumatoid Arthritis in 314 participants. Terminated before completion.

Timeline

24 April 2008

Primary endpoint
26 October 2009

26 October 2009

Quick facts

Lead sponsor	Genentech, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	314
Start date	24 April 2008
Primary completion	26 October 2009
Estimated completion	26 October 2009

Drugs / interventions tested

Methotrexate — full drug profile →
Ocrelizumab (OCRELIZUMAB) — full drug profile →
Placebo

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Genentech, Inc. — 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.

Percentage of Participants With American College of Rheumatology (ACR) 20 Response Primary · Week 24

ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \[VAS\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.

Group	Value	95% CI
Placebo	28.1	17.1 – 39.1
Ocrelizumab 400mg	37.6	28.8 – 46.4
Ocrelizumab 200mg - Cycle 1	52.7	44.1 – 61.2

Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6) Secondary · Week 24

The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged

Group	Value	95% CI
Placebo	3.1
Ocrelizumab 400mg	4.3
Ocrelizumab 200mg - Cycle 1	5.3

Change in DAS28 From Baseline Secondary · Week 24

Group	Value	95% CI
Placebo	-0.79	± 1.293
Ocrelizumab 400mg	-1.60	± 1.374
Ocrelizumab 200mg - Cycle 1	-1.67	± 1.320

European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders) Secondary · Week 24

Week 4 No Response

Group	Value	95% CI
Placebo	62.5
Ocrelizumab 400mg	62.4
Ocrelizumab 200mg - Cycle 1	58.0

Week 4 Moderate Response

Group	Value	95% CI
Placebo	37.5
Ocrelizumab 400mg	33.3
Ocrelizumab 200mg - Cycle 1	38.9

Week 4 Good Response

Group	Value	95% CI
Placebo	0
Ocrelizumab 400mg	4.3
Ocrelizumab 200mg - Cycle 1	3.1

Week 8 No Response

Group	Value	95% CI
Placebo	70.3
Ocrelizumab 400mg	52.1
Ocrelizumab 200mg - Cycle 1	48.1

Week 8 Moderate Response

Group	Value	95% CI
Placebo	28.1
Ocrelizumab 400mg	39.3
Ocrelizumab 200mg - Cycle 1	42.0

Week 8 Good Response

Group	Value	95% CI
Placebo	1.6
Ocrelizumab 400mg	8.5
Ocrelizumab 200mg - Cycle 1	9.9

Week 12 No Response

Group	Value	95% CI
Placebo	68.8
Ocrelizumab 400mg	41.9
Ocrelizumab 200mg - Cycle 1	35.9

Week 12 Moderate Response

Group	Value	95% CI
Placebo	29.7
Ocrelizumab 400mg	49.6
Ocrelizumab 200mg - Cycle 1	54.2

Percentage of Participants Achieving an ACR50 Response Secondary · Week 24

The ACR50 response at any time was defined as \>/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).

Group	Value	95% CI
Placebo	7.8
Ocrelizumab 400mg	18.8
Ocrelizumab 200mg - Cycle 1	30.5

Percentage of Participants Achieving an ACR70 Response Secondary · Week 24

The ACR70 response at any time was defined as \>/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).

Group	Value	95% CI
Placebo	1.6
Ocrelizumab 400mg	6.8
Ocrelizumab 200mg - Cycle 1	7.6

Change From Baseline in the Individual Parameters of the ACR Core Set Secondary · Week 24

Change in the scores of the following parameters of ACR core set relative to respective baseline scores was measured: SJC (28 and 66 joints) and TJC (28 and 66 joints), patient's global assessment and physician's global assessment based on disease activity (both are expressed by VAS \[0 = no disease activity to 100 = maximum disease activity\]), HAQ (based on HAQ disability index \[HAQDI\]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of

SJC

Group	Value	95% CI
Placebo	-4.6
Ocrelizumab 400mg	-7.5
Ocrelizumab 200mg - Cycle 1	-8.7

TJC

Group	Value	95% CI
Placebo	-8.2
Ocrelizumab 400mg	-10.2
Ocrelizumab 200mg - Cycle 1	-12.0

Patient's global assessment

Group	Value	95% CI
Placebo	-7.6
Ocrelizumab 400mg	-21.2
Ocrelizumab 200mg - Cycle 1	-24.3

Physician's global assessment

Group	Value	95% CI
Placebo	-16.0
Ocrelizumab 400mg	-24.3
Ocrelizumab 200mg - Cycle 1	-26.0

Patient's pain assessment

Group	Value	95% CI
Placebo	-8.0
Ocrelizumab 400mg	-17.2
Ocrelizumab 200mg - Cycle 1	-21.0

HAQ-DI

Group	Value	95% CI
Placebo	-0.2
Ocrelizumab 400mg	-0.4
Ocrelizumab 200mg - Cycle 1	-0.5

Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration Secondary · Week 24

Group	Value	95% CI
Placebo	-0.2
Ocrelizumab 400mg	-1.0
Ocrelizumab 200mg - Cycle 1	-0.8

Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR) Secondary · Week 24

Group	Value	95% CI
Placebo	-3.0
Ocrelizumab 400mg	-14.2
Ocrelizumab 200mg - Cycle 1	-11.1

Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score Secondary · Week 24

Group	Value	95% CI
Placebo	37.5	25.6 – 49.4
Ocrelizumab 400mg	55.6	46.6 – 64.6
Ocrelizumab 200mg - Cycle 1	58.8	50.3 – 67.2

Change in SF-36 Subscale and Summary Scores From Baseline Secondary · Week 24

Improved, change \> 5.42; Unchanged, -5.42 \<= Change \<= 5.42; Worsened, change \< -5.42

Mental Component Summary Category Improved

Group	Value	95% CI
Placebo	42.0
Ocrelizumab 400mg	34.9
Ocrelizumab 200mg - Cycle 1	36.6

Mental Component Summary Category Unchanged

Group	Value	95% CI
Placebo	38.0
Ocrelizumab 400mg	50.0
Ocrelizumab 200mg - Cycle 1	51.2

Mental Component Summary Category Worsened

Group	Value	95% CI
Placebo	20.0
Ocrelizumab 400mg	15.1
Ocrelizumab 200mg - Cycle 1	12.2

Physical Component Improved

Group	Value	95% CI
Placebo	44.0
Ocrelizumab 400mg	45.3
Ocrelizumab 200mg - Cycle 1	53.7

Physical Component Unchanged

Group	Value	95% CI
Placebo	42.0
Ocrelizumab 400mg	51.9
Ocrelizumab 200mg - Cycle 1	42.3

Physical Component Worsened

Group	Value	95% CI
Placebo	14.0
Ocrelizumab 400mg	2.8
Ocrelizumab 200mg - Cycle 1	4.1

Change in FACIT-F Fatigue Assessment From Baseline Secondary · Baseline, Weeks 4, 12, and 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. FACIT-F is a 13-item questionnaire. 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 r

Baseline

Group	Value	95% CI
Placebo	25.13	± 10.616
Ocrelizumab 400mg	25.33	± 11.313
Ocrelizumab 200mg - Cycle 1	24.74	± 11.161

Week 4

Group	Value	95% CI
Placebo	28.94	± 11.371
Ocrelizumab 400mg	28.60	± 11.231
Ocrelizumab 200mg - Cycle 1	30.71	± 11.136

Week 12

Group	Value	95% CI
Placebo	28.42	± 12.015
Ocrelizumab 400mg	32.09	± 12.368
Ocrelizumab 200mg - Cycle 1	33.09	± 10.903

Week 24

Group	Value	95% CI
Placebo	28.47	± 12.406
Ocrelizumab 400mg	31.38	± 11.346
Ocrelizumab 200mg - Cycle 1	33.18	± 11.011

Adverse events — posted to ClinicalTrials.gov

Time frame: From baseline up to 17 months. Reporting threshold: 0.05%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 5/64 (8%)

Deaths: 0/64

Ocrelizumab 400mg

Serious: 3/117 (3%)

Deaths: 0/117

Ocrelizumab 200mg

Serious: 2/131 (2%)

Deaths: 0/131

Ocrelizumab 200mg/ Ocrelizumab 200mg

Serious: 5/61 (8%)

Deaths: 0/61

Ocrelizumab 200mg/ Ocrelizumab 400mg

Serious: 5/61 (8%)

Deaths: 0/61

Ocrelizumab 400mg/ Ocrelizumab 400mg

Serious: 10/109 (9%)

Deaths: 1/109

Placebo/ Ocrelizumab 200mg

Serious: 3/29 (10%)

Deaths: 0/29

Placebo/ Ocrelizumab 400mg

Serious: 0/28 (0%)

Deaths: 0/28

Serious adverse events (27 terms)

Reaction	System	Placebo	Ocrelizumab 400mg	Ocrelizumab 200mg	Ocrelizumab 200mg/ Ocreliz…	Ocrelizumab 200mg/ Ocreliz…	Ocrelizumab 400mg/ Ocreliz…	Placebo/ Ocrelizumab 200mg	Placebo/ Ocrelizumab 400mg
BRONCHIECTASIS	Infections and infestations	—	—	—	—	—	—	—	—
MYCOBACTERIUM ABSCESSUS INFECTION	Infections and infestations	—	—	—	—	—	—	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—
COLITIS ULCERATIVE	Gastrointestinal disorders	—	—	—	—	—	—	—	—
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
CELLULITIS	Infections and infestations	—	—	—	—	—	—	—	—
PNEUMONIA	Infections and infestations	—	—	—	—	—	—	—	—
PROSTATE INFECTION	Infections and infestations	—	—	—	—	—	—	—	—
INFLUENZA LIKE ILLNESS	General disorders	—	—	—	—	—	—	—	—
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
DEPRESSION	Psychiatric disorders	—	—	—	—	—	—	—	—
COLITIS	Gastrointestinal disorders	—	—	—	—	—	—	—	—
COLITIS ISCHAEMIC	Gastrointestinal disorders	—	—	—	—	—	—	—	—
DIVERTICULAR PERFORATION	Gastrointestinal disorders	—	—	—	—	—	—	—	—
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	—	—	—	—	—	—	—	—
PANCREATITIS	Gastrointestinal disorders	—	—	—	—	—	—	—	—
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—
PYELONEPHRITIS	Infections and infestations	—	—	—	—	—	—	—	—
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
ATRIAL FIBRILLATION	Cardiac disorders	—	—	—	—	—	—	—	—
MYOCARDIAL INFARCTION	Cardiac disorders	—	—	—	—	—	—	—	—
CATARACT	Eye disorders	—	—	—	—	—	—	—	—
CHEST PAIN	General disorders	—	—	—	—	—	—	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	Placebo	Ocrelizumab 400mg	Ocrelizumab 200mg	Ocrelizumab 200mg/ Ocreliz…	Ocrelizumab 200mg/ Ocreliz…	Ocrelizumab 400mg/ Ocreliz…	Placebo/ Ocrelizumab 200mg	Placebo/ Ocrelizumab 400mg
INFUSION RELATED REACTION	General disorders	—	—	—	—	—	—	—	—
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—	—	—	—	—	—	—
BRONCHITIS	Infections and infestations	—	—	—	—	—	—	—	—
NAUSEA	Gastrointestinal disorders	—	—	—	—	—	—	—	—
HEADACHE	Nervous system disorders	—	—	—	—	—	—	—	—
HYPERTENSION	Vascular disorders	—	—	—	—	—	—	—	—
NASOPHARYNGITIS	Infections and infestations	—	—	—	—	—	—	—	—
FATIGUE	General disorders	—	—	—	—	—	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—	—	—	—	—	—
SINUSITIS	Infections and infestations	—	—	—	—	—	—	—	—
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	—	—	—	—	—	—	—	—
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
RASH	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
JOINT INJURY	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—

Most-reported serious reactions: BRONCHIECTASIS, MYCOBACTERIUM ABSCESSUS INFECTION, URINARY TRACT INFECTION, COLITIS ULCERATIVE, DYSPNOEA, CELLULITIS, PNEUMONIA, PROSTATE INFECTION.

Data from ClinicalTrials.gov NCT00673920 adverse events section.

Sponsor's own description

This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.

Publications & conference data

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

Next-generation anti-CD20 monoclonal antibodies in autoimmune disease treatment.
Du FH, Mills EA, Mao-Draayer Y. · · 2017 · cited 120× · PMID 29143151 · DOI 10.1007/s13317-017-0100-y
Antibodies to watch in 2010.
Reichert JM. · · 2010 · cited 68× · PMID 20065640 · DOI 10.4161/mabs.2.1.10677
Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program.
Emery P, Rigby W, Tak PP, Dörner T, et al · · 2014 · cited 61× · PMID 24498318 · DOI 10.1371/journal.pone.0087379
Next generation and biosimilar monoclonal antibodies: essential considerations towards regulatory acceptance in Europe. February 3-4, 2011, Freiburg, Germany.
Reichert JM. · · 2011 · cited 23× · PMID 21487235 · DOI 10.4161/mabs.3.3.15475

Verify or expand the search:

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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 NCT00673920 (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 Genentech, Inc.
Last refreshed: 4 December 2020

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/NCT00673920.

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