Rheumatoid ArthritisPhase 3FILMNCT00485589

A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)

A Phase 3 study testing Methotrexate and Ocrelizumab in people with Rheumatoid Arthritis, run by Genentech, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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: 613 participants
Where: No sites listed yet
Study dates: 11 Jun 2007to 29 Aug 2013
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

Age ≥ 18
Rheumatoid arthritis for 3 months-5 years
Naive to methotrexate
If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to baseline

Who cannot join

Rheumatic autoimmune disease or inflammatory joint disease other than RA
Prior receipt of any biologic therapy for RA
Concurrent treatment with any DMARD

About this study

Official title: A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab in Combination With Methotrexate (MTX) Compared to MTX Alone in Methotrexate- Naive Patients With Active Rheumatoid Arthritis

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who are naive to methotrexate. Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on Days 1 and 15. Repeat courses of i.v. treatment will be administered at weeks 24, 52 and 76. All patients will receive concomitant methotrexate (7.5 mg escalating to 20mg p.o. weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions: Rheumatoid Arthritis
Being tested: Methotrexate, Ocrelizumab, Placebo
Keywords: FILM, RA, anti-CD20, CD20
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 repeating dose
OcrelizumabDrug
Intravenous repeating dose
PlaceboDrug
Intravenous repeating dose

Study groups in NCT00485589
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. Receives: Drug: Placebo
Ocrelizumab 200 mg	Experimental	Participants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. Receives: Drug: Methotrexate; Drug: Ocrelizumab
Ocrelizumab 500 mg	Experimental	Participants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone. Receives: Drug: Methotrexate; Drug: Ocrelizumab

What is being measured

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

Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 52
The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.
Measured: Baseline to Week 52

Secondary outcomes (3)

Percentage of Participants Without Radiographic Progression (RP) at Week 52
RP was defined as a change from Baseline in the modified Total Sharp Score (mTSS) ≤ 0. The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.
Measured: Week 52
Percentage of Participants With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Week 52
Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "none" [symptom-free and no arthritis symptoms] and the extreme right end "maximum" [maximum arthritis disease activity]; patient assessment of pain in the previous 24 hours on a VAS (extreme left end of the line "none" and the extreme right end "unbearable"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing.
Measured: Baseline to Week 52
Percentage of Participants in Disease Activity Score 28 (DAS28) Remission at Weeks 24 and 52
A participant was in DAS28 remission if their DAS28 score < 2.6). The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score indicates more disease activity.
Measured: Week 24 and Week 52

Timeline

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

11 Jun 200729 Aug 2013

First posted13 Jun 2007 (estimated)
Study start11 Jun 2007
Primary completion29 Jan 2010
Study completion29 Aug 2013

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: 613 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00485589
Sponsor's protocol ID: ACT3984g
Other IDs: WA20497
Acronym: FILM
Status last verified: Oct 2020
First submitted: 11 Jun 2007
Last updated: 3 Nov 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

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?

Official record

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 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 in Combination With Methotrexate (MTX) Compared to MTX Alone in Methotrexate- Naive Patients With Active Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT00485589
Acronym / sponsor ID: FILM / ACT3984g
Conditions: Rheumatoid Arthritis
Keywords: FILM, RA, anti-CD20, CD20
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: 613 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Collaborators: Roche Pharma AG
Study start: 11 Jun 2007 (actual)
Primary completion: 29 Jan 2010 (actual)
Study completion: 29 Aug 2013 (actual)
First posted: 13 Jun 2007 (estimated)
Results: Posted 3 Nov 2020

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, 76, and 78. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Ocrelizumab 200 mg	Experimental	Drug: Methotrexate, Drug: OcrelizumabParticipants received ocrelizumab 200 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54 and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.
Ocrelizumab 500 mg	Experimental	Drug: Methotrexate, Drug: OcrelizumabParticipants received ocrelizumab 500 mg intravenously on Days 1 and 15 and Weeks 24, 26, 52, 54, and 76. Participants also received methotrexate 7.5 mg orally weekly starting on Day 1. The dose of methodrexate was increased to a dose of 20 mg per week by Week 8, administered in 1 dose or divided into 3 equal doses administered at 12-hour intervals. Participants also received folate ≥ 5 mg/week either as a single dose or as a divided weekly dose. Participants were also allowed to continue receiving background corticosteroid therapy, at a dose of ≤ 10 mg/day of prednisolone or prednisolone.

Who may qualify

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

Key inclusion criteria (4 listed)

Age ≥ 18
Rheumatoid arthritis for 3 months-5 years
Naive to methotrexate
If receiving steroids or NSAIDs, must be on a stable dose for 4 weeks prior to baseline

Key exclusion criteria (3 listed)

Rheumatic autoimmune disease or inflammatory joint disease other than RA
Prior receipt of any biologic therapy for RA
Concurrent treatment with any DMARD

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 repeating dose	Drug	Ocrelizumab 200 mg, Ocrelizumab 500 mg
OcrelizumabIntravenous repeating dose	Drug	Ocrelizumab 200 mg, Ocrelizumab 500 mg
PlaceboIntravenous repeating dose	Drug	Placebo

Primary outcome

Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 52
Time frame: Baseline to Week 52
The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space narrowing. The mTSS ranges from 0 to 448 (280+168). A higher mTSS score indicates greater damage. A negative change score indicates improvement.

3 secondary outcomes

Percentage of Participants Without Radiographic Progression (RP) at Week 52
Time frame: Week 52
Percentage of Participants With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Week 52
Time frame: Baseline to Week 52
Percentage of Participants in Disease Activity Score 28 (DAS28) Remission at Weeks 24 and 52
Time frame: Week 24 and Week 52

Results and safety

Results posted to the registry on 3 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	210	183
Ocrelizumab 200 mg	200	180
Ocrelizumab 500 mg	203	185

Primary outcome: Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 52

Time frame: Baseline to Week 52. Mean (Standard Deviation). Unit: Units on a scale

Measure	Placebo n = 193	Ocrelizumab 200 mg n = 187	Ocrelizumab 500 mg n = 194
Value	1.59 (4.815)	0.66 (4.509)	0.27 (2.908)

Placebo vs Ocrelizumab 200 mg: p = 0.001, Van Elteren's test
Placebo vs Ocrelizumab 500 mg: p = 0.0033, Van Elteren's test

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 30 months.. Other adverse events reported at 0.05% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Treatment Period	22 of 207 (10.6%)	128 of 207 (61.8%)	0 of 207
Placebo/Ocrelizumab 500 mg - Treatment Period	0 of 10 (0%)	4 of 10 (40%)	0 of 10
Ocrelizumab 200 mg - Treatment Period	21 of 196 (10.7%)	135 of 196 (68.9%)	0 of 196
Ocrelizumab 200 mg/Ocrelizumab 500 mg - Treatment Period	1 of 12 (8.3%)	6 of 12 (50%)	0 of 12
Ocrelizumab 500 mg - Treatment Period	31 of 202 (15.3%)	144 of 202 (71.3%)	0 of 202
Ocrelizumab 500 mg/Ocrelizumab 500 mg - Treatment Period	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Placebo - Safety Follow-up Period	11 of 187 (5.9%)	35 of 187 (18.7%)	2 of 187
Placebo/Ocrelizumab 500 mg - Safety Follow-up Period	2 of 9 (22.2%)	3 of 9 (33.3%)	0 of 9
Ocrelizumab 200 mg - Safety Follow-up Period	2 of 177 (1.1%)	32 of 177 (18.1%)	2 of 177
Ocrelizumab 200 mg/Ocrelizumab 500 Mg-safety Follow-up Period	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Ocrelizumab 500 mg - Safety Follow-up Period	4 of 185 (2.2%)	49 of 185 (26.5%)	1 of 185
Ocrelizumab 500 mg/Ocrelizumab 500 mg -Safety Follow-up Period	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Limitations and caveats (from the sponsor): The study was terminated prematurely by the sponsors before all patients could reach the time point for primary analysis at Week 104. No patient received any further infusions of study medication.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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 4 inclusion and 3 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 3 Nov 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 3 Nov 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?

Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 52 (time frame: Baseline to Week 52). 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 NCT00485589, 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 3 Nov 2020.