Rheumatoid ArthritisPhase 3FEATURENCT00673920
A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
A Phase 3 study testing Methotrexate and Ocrelizumab in people with Rheumatoid Arthritis, run by Genentech, Inc..
Trial summary
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. 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?
- Methotrexate and Ocrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- 24 Apr 2008to 26 Oct 2009
- Phase
- Phase 3
- 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 rheumatoid arthritis
- Inadequate treatment with any DMARD other than methotrexate
Who cannot join
- Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
- Concurrent treatment with any DMARD other than methotrexate
- Previous treatment with any cell-depleting therapies
- Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Methotrexate, Ocrelizumab, Placebo
- Keywords
- RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Oral or parenteral repeating dose
OcrelizumabDrug
Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).
Ocrelizumab was administered in combination with Methotrexate.
PlaceboDrug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received matching placebo:
* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)
* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group) Receives: Drug: Methotrexate; Drug: Placebo |
| Ocrelizumab 400mg | Experimental | Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1. Receives: Drug: Methotrexate; Drug: Ocrelizumab |
| Ocrelizumab 200mg | Experimental | Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1. Receives: Drug: Methotrexate; Drug: Ocrelizumab |
| Ocrelizumab 200mg/ Ocrelizumab 200mg | Experimental | Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2 Receives: Drug: Methotrexate; Drug: Ocrelizumab |
| Ocrelizumab 200mg/ Ocrelizumab 400mg | Experimental | Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2 Receives: Drug: Methotrexate; Drug: Ocrelizumab |
| Ocrelizumab 400mg/ Ocrelizumab 400mg | Experimental | Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2 Receives: Drug: Methotrexate; Drug: Ocrelizumab |
| Placebo/ Ocrelizumab 200mg | Experimental | Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2 Receives: Drug: Methotrexate; Drug: Ocrelizumab; Drug: Placebo |
| Placebo/ Ocrelizumab 400mg | Experimental | Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2 Receives: Drug: Methotrexate; Drug: Ocrelizumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With American College of Rheumatology (ACR) 20 Response
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.
Measured: Week 24
Secondary outcomes (17)
Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6)
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 among all participants, where negative changes indicated an improvement in disease activity.
Measured: Week 24
Change in DAS28 From Baseline
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 among all participants, where negative changes indicated an improvement in disease activity. The change is the difference in adjusted mean change from baseline in DAS28 between ocrelizumab 400 x 1 and ocrelizumab 200 x 2 with placebo.
Measured: Week 24
European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders)
Measured: Week 24
Percentage of Participants Achieving an ACR50 Response
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).
Measured: Week 24
Percentage of Participants Achieving an ACR70 Response
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).
Measured: Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set
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 scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain).
Measured: Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration
Measured: Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR)
Measured: Week 24
Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score
Measured: Week 24
Change in SF-36 Subscale and Summary Scores From Baseline
Improved, change > 5.42; Unchanged, -5.42 <= Change <= 5.42; Worsened, change < -5.42
Measured: Week 24
Change in FACIT-F Fatigue Assessment From Baseline
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 resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.
Measured: Baseline, Weeks 4, 12, and 24
Percentage of Participants Achieving an ACR20 Response
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.
Measured: Week 48
Percentage of Participants Achieving an ACR50 Response
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).
Measured: Week 48
Percentage of Participants Achieving an ACR70 Response
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).
Measured: Week 48
Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6)
Measured: Week 48
Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion
Measured: Week 24, 48
Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion
Measured: Day 15 of Cycles 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study start24 Apr 2008
- Primary completion26 Oct 2009
- Study completion26 Oct 2009
Why it stopped: Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Wolfgang Dummer, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673920
- Sponsor's protocol ID
- ACT4394g
- Other IDs
- WA20496
- Acronym
- FEATURE
- Status last verified
- Nov 2020
- First submitted
- 5 May 2008
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Publications
Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.
PubMed 24498318
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
- ClinicalTrials.gov ID
- NCT00673920
- Acronym / sponsor ID
- FEATURE / ACT4394g
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Roche Pharma AG
- Study start
- 24 Apr 2008 (actual)
- Primary completion
- 26 Oct 2009 (actual)
- Study completion
- 26 Oct 2009 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 4 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Methotrexate, Drug: PlaceboParticipants received matching placebo: * on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate) * on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group) |
| Ocrelizumab 400mg | Experimental | Drug: Methotrexate, Drug: OcrelizumabParticipants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1. |
| Ocrelizumab 200mg | Experimental | Drug: Methotrexate, Drug: OcrelizumabParticipants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1. |
| Ocrelizumab 200mg/ Ocrelizumab 200mg | Experimental | Drug: Methotrexate, Drug: OcrelizumabParticipants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2 |
| Ocrelizumab 200mg/ Ocrelizumab 400mg | Experimental | Drug: Methotrexate, Drug: OcrelizumabParticipants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2 |
| Ocrelizumab 400mg/ Ocrelizumab 400mg | Experimental | Drug: Methotrexate, Drug: OcrelizumabParticipants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2 |
| Placebo/ Ocrelizumab 200mg | Experimental | Drug: Methotrexate, Drug: Ocrelizumab, Drug: PlaceboParticipants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2 |
| Placebo/ Ocrelizumab 400mg | Experimental | Drug: Methotrexate, Drug: Ocrelizumab, Drug: PlaceboParticipants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients, ≥ 18 years of age
- Active rheumatoid arthritis
- Inadequate treatment with any DMARD other than methotrexate
Key exclusion criteria (4 listed)
- Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
- Concurrent treatment with any DMARD other than methotrexate
- Previous treatment with any cell-depleting therapies
- Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline
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 |
|---|---|---|
| MethotrexateOral or parenteral repeating dose | Drug | Ocrelizumab 200mg, Ocrelizumab 200mg/ Ocrelizumab 200mg, Ocrelizumab 200mg/ Ocrelizumab 400mg, Ocrelizumab 400mg, Ocrelizumab 400mg/ Ocrelizumab 400mg, Placebo, Placebo/ Ocrelizumab 200mg, Placebo/ Ocrelizumab 400mg |
| OcrelizumabOcrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1). Ocrelizumab was administered in combination with Methotrexate. | Drug | Ocrelizumab 200mg, Ocrelizumab 200mg/ Ocrelizumab 200mg, Ocrelizumab 200mg/ Ocrelizumab 400mg, Ocrelizumab 400mg, Ocrelizumab 400mg/ Ocrelizumab 400mg, Placebo/ Ocrelizumab 200mg, Placebo/ Ocrelizumab 400mg |
| PlaceboIntravenous repeating dose | Drug | Placebo, Placebo/ Ocrelizumab 200mg, Placebo/ Ocrelizumab 400mg |
Primary outcome
Percentage of Participants With American College of Rheumatology (ACR) 20 Response
Time frame: 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.
17 secondary outcomes
Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6)
Time frame: Week 24
Change in DAS28 From Baseline
Time frame: Week 24
European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders)
Time frame: Week 24
Percentage of Participants Achieving an ACR50 Response
Time frame: Week 24
Percentage of Participants Achieving an ACR70 Response
Time frame: Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set
Time frame: Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration
Time frame: Week 24
Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR)
Time frame: Week 24
Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score
Time frame: Week 24
Change in SF-36 Subscale and Summary Scores From Baseline
Time frame: Week 24
Change in FACIT-F Fatigue Assessment From Baseline
Time frame: Baseline, Weeks 4, 12, and 24
Percentage of Participants Achieving an ACR20 Response
Time frame: Week 48
Percentage of Participants Achieving an ACR50 Response
Time frame: Week 48
Percentage of Participants Achieving an ACR70 Response
Time frame: Week 48
Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6)
Time frame: Week 48
Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion
Time frame: Week 24, 48
Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion
Time frame: Day 15 of Cycles 1 and 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24498318Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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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.
Wolfgang Dummer, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate and Ocrelizumab in people with Rheumatoid Arthritis, run by Genentech, Inc..
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Dec 2020). 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?
Percentage of Participants With American College of Rheumatology (ACR) 20 Response (time frame: Week 24). 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 NCT00673920, which also lists 1 linked publication.
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 4 Dec 2020.