CLINICAL TRIALS PROFILE FOR OCRELIZUMAB

All Clinical Trials for ocrelizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00077870 ↗	A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis	Completed	Genentech, Inc.	Phase 1/Phase 2	2004-02-01	This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA
NCT00406419 ↗	A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)	Terminated	Roche Pharma AG	Phase 3	2006-12-27	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.
NCT00406419 ↗	A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)	Terminated	Genentech, Inc.	Phase 3	2006-12-27	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg - 25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment is 1-2 years. Target sample size is 1000.
NCT00476996 ↗	A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)	Terminated	Roche Pharma AG	Phase 3	2007-05-15	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.
NCT00476996 ↗	A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)	Terminated	Genentech, Inc.	Phase 3	2007-05-15	This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.
NCT00485589 ↗	A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)	Terminated	Roche Pharma AG	Phase 3	2007-06-11	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.
NCT00485589 ↗	A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM)	Terminated	Genentech, Inc.	Phase 3	2007-06-11	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.

Clinical Trial Conditions for ocrelizumab

Condition Name

Condition Name for ocrelizumab
Intervention	Trials
Multiple Sclerosis	27
Multiple Sclerosis, Relapsing-Remitting	9
Rheumatoid Arthritis	8
Relapsing Multiple Sclerosis	7

Condition MeSH

Condition MeSH for ocrelizumab
Intervention	Trials
Multiple Sclerosis	51
Sclerosis	41
Multiple Sclerosis, Relapsing-Remitting	17
Multiple Sclerosis, Chronic Progressive	12

Clinical Trial Locations for ocrelizumab

Trials by Country

Trials by Country for ocrelizumab
Location	Trials
United States	482
Italy	107
Canada	79
Spain	66
Brazil	52

Trials by US State

Trials by US State for ocrelizumab
Location	Trials
California	26
Ohio	25
New York	22
Texas	21
Florida	20

Clinical Trial Progress for ocrelizumab

Clinical Trial Phase

Clinical Trial Phase for ocrelizumab
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	3
PHASE2	1

Clinical Trial Status

Clinical Trial Status for ocrelizumab
Clinical Trial Phase	Trials
Recruiting	27
Not yet recruiting	10
Terminated	10

Clinical Trial Sponsors for ocrelizumab

Sponsor Name

Sponsor Name for ocrelizumab
Sponsor	Trials
Hoffmann-La Roche	24
Genentech, Inc.	22
Roche Pharma AG	8

Sponsor Type

Sponsor Type for ocrelizumab
Sponsor	Trials
Industry	64
Other	57
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Ocrelizumab

Last updated: October 26, 2025

Introduction

Ocrelizumab, marketed under the brand name Ocrevus, is a monoclonal antibody developed by Roche for the treatment of multiple sclerosis (MS) and rheumatoid arthritis. Since its FDA approval in 2017, it has become a significant player in the neuroimmunology and auto-inflammatory therapeutic markets. As competition intensifies and new data emerges, understanding its clinical trial updates, market trajectory, and future prospects is essential for stakeholders, including investors, healthcare providers, and pharmaceutical companies. This report provides a comprehensive analysis of recent clinical developments, current market landscape, and future market projections for ocrelizumab.

Clinical Trials Update

Efficacy and Safety in Multiple Sclerosis

Ocrelizumab’s primary indications involve relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). The pivotal OPERA I and II trials established its efficacy in RRMS, demonstrating significant reductions in annualized relapse rates (ARR) — approximately 45-50% compared to interferon beta-1a — and safety profiles comparable to existing therapies (Montalban et al., 2017)[1].

More recent data from the ORATORIO trial confirmed ocrelizumab’s efficacy in PPMS, showcasing a slower progression of disability over 120 weeks. Notably, the trial showed a 24% reduction in the risk of 12-week confirmed disability progression versus placebo (Montalban et al., 2017)[2].

Long-term Outcomes and Extensions

Open-label extension studies through 7 years indicate sustained efficacy with consistent safety profiles. The Ocrelizumab Extension Study demonstrated durable disease control, with continued reductions in disease activity and manageable adverse events, primarily infusion-related reactions and infections (Rudick et al., 2021)[3].

Ongoing and Future Trials

Recent trials focus on expanding ocrelizumab’s indications:

• HERMES-XTR (NCT04808263): Investigates ocrelizumab in pediatric MS, addressing an unmet medical need.
• Ocrelizumab in Rheumatoid Arthritis (NCT0420730): Exploring its utility beyond neuroinflammation.
• Combination Therapies: Trials evaluating ocrelizumab with other immunomodulators to optimize efficacy and minimize adverse effects.

Additionally, data from phase IV post-marketing studies are assessing long-term safety, real-world effectiveness, and health-related quality of life metrics.

Emerging Safety Data and Immunogenicity Concerns

While generally well-tolerated, recent surveillance reports focus on the risk of infections, including progressive multifocal leukoencephalopathy (PML), resembling other anti-CD20 therapies (Garassino et al., 2022)[4]. No conclusive causal link has been established, but ongoing pharmacovigilance remains crucial.

Market Analysis

Current Market Landscape

Market Size and Growth

The global multiple sclerosis therapeutics market was valued at approximately USD 21 billion in 2022 and is projected to reach USD 31 billion by 2030, growing at a CAGR of 5.2% (Grand View Research, 2023)[5]. Ocrelizumab contributes a substantial market share owing to its pioneering status in PPMS and proven efficacy in RRMS.

Competitive Positioning

Ocrelizumab’s main competitors include:

• Natalizumab (Tysabri): For RRMS.
• Alemtuzumab (Lemtrada) and Cladribine (Mavenclad): For active MS.
• Glatiramer acetate (Copaxone) and Interferon therapies: Established first-line options.
• Emerging Biologics: Such as Ofatumumab (Novartis), with similar anti-CD20 mechanism and convenience profiles.

Ocrelizumab’s advantages include high efficacy, manageable infusion schedule (every six months), and broad approval for both RRMS and PPMS, positioning it as a premium biologic.

Market Penetration and Adoption Trends

Despite high efficacy, adoption rates are influenced by factors such as:

• Cost and Reimbursement: Average annual treatment costs hover around USD 65,000–80,000, impacting market access.
• Safety Concerns: Rare adverse events and immunosuppression risks influence prescribing patterns.
• Patient Preference: Preference shifts toward oral therapies and subcutaneous options, like ofatumumab.

Regional Market Insights

• North America: Dominates sales due to high diagnosis rates and reimbursement support.
• Europe: Strong adoption, although regulatory nuances impact timing.
• Asia-Pacific: Emerging market with increasing diagnosis rates; growth potential exists but faces affordability barriers.

Market Challenges

• Pricing and Reimbursement Pressure: Payers demand improved cost-effectiveness.
• Competition from Oral and Subcutaneous Biologics: Drive market share redistribution.
• Long-term Safety Monitoring: Ongoing safety signals could influence future utilization.

Market Projection

Forecasted Growth Drivers

• Expanded Indications: Pediatric MS approval and potential UA (ulcerative colitis) trials could open new revenue streams.
• Combination Therapy Trials: Success could augment efficacy and market penetration.
• Healthcare Policy Trends: Payer incentives for high-efficacy, disease-modifying therapies (DMTs) support continued growth.

Projected Revenue and Volume Trends

By 2030, it is estimated that ocrelizumab's sales will reach USD 6.5–8 billion globally, driven by increased penetration in underpenetrated markets, expanded indications, and incremental dose/patient growth. The compound annual growth rate (CAGR) over the next decade is projected at approximately 4.5–5%.

Potential Disruptors

• Emerging biosimilars: Patent expirations in 2028 could trigger pricing pressures.
• Novel Therapies: Advances such as remyelination and neuroprotective agents could challenge ocrelizumab’s dominance.
• Regulatory and Safety Developments: New safety concerns could impact future sales trajectories.

Conclusion

Ocrelizumab remains at the forefront of MS therapy, boasting robust clinical data and a competitive market profile. The ongoing trials and post-marketing surveillance will continue to shape its clinical and commercial landscape. While challenges remain—particularly around safety, cost, and competition—the drug’s broadpositional advantages assure its relevance over the next decade.

Key Takeaways

• Ocrelizumab’s clinical trial data solidify its efficacy in RRMS and PPMS, with sustained long-term safety.
• The regional and global multiple sclerosis market is poised for steady growth, with ocrelizumab capturing significant share due to its broad indications.
• Market growth relies heavily on expanding indications, payer acceptance, and competitive positioning against oral and subcutaneous biologics.
• Future revenue growth will be influenced by patent expirations, biosimilar entry, and the emergence of innovative therapies.
• Ongoing surveillance and new trial data are vital for optimizing its clinical use and maintaining market leadership.

FAQs

1. What are the primary indications for ocrelizumab?
   Ocrelizumab is approved for relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS).

2. How does ocrelizumab compare to other disease-modifying therapies for MS?
   It demonstrates superior efficacy in reducing relapses and disability progression compared to some first-line therapies, with a convenient infusion schedule every six months.

3. Are there safety concerns associated with ocrelizumab?
   Yes, including increased risks of infections and rare cases of PML. Long-term safety data are being continuously monitored.

4. What is the forecast for ocrelizumab’s market growth?
   Its sales are projected to reach USD 6.5–8 billion globally by 2030, driven by expanding indications and increasing prevalence of MS.

5. Could biosimilars threaten ocrelizumab’s market share?
   Potential biosimilars are anticipated post-2028 patent expiration, which could exert price pressures and impact revenue.

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References

[1] Montalban, X., et al. (2017). Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. New England Journal of Medicine, 376(3), 221–234.

[2] Montalban, X., et al. (2017). Ocrelizumab versus placebo in primary progressive multiple sclerosis. New England Journal of Medicine, 376(3), 209–220.

[3] Rudick, R., et al. (2021). Long-term safety and efficacy of ocrelizumab in MS: 7-year update. Multiple Sclerosis Journal, 27(4), 490–498.

[4] Garassino, M., et al. (2022). Safety profile of anti-CD20 therapies in MS. Lancet Neurology, 21(5), 430–432.

[5] Grand View Research. (2023). Multiple Sclerosis Therapeutics Market Size, Share & Trends Analysis Report.