AzTrials
AzTrials

Systemic Lupus ErythematosusPhase 2NCT00962832

A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus

A Phase 2 study testing Rontalizumab in people with Systemic Lupus Erythematosus, run by Genentech, Inc. at 79 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Rontalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
238 participants
Where
79 sitesin 6 countries
Study dates
Sep 2009to Aug 2013
Phase
Phase 2
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of SLE.
  • Active disease at the time of screening.
  • Agreement to use an effective form of contraception for the duration of the study.

Who cannot join

  • Acutely life- or organ-threatening manifestations of systemic lupus erythematosus (SLE) (eg, proliferative nephritis, unstable neuropsychiatric disease).
  • Pregnancy or breastfeeding.
  • History of severe allergic or anaphylactic reactions to monoclonal antibodies or intravenous (IV) immunoglobulin.
  • Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude patient participation.
  • Concomitant conditions that required systemic corticosteroid use within 1 year prior to screening. Use of topical, intraarticular, or inhaled corticosteroids is not exclusionary.
  • History of cancer within 5 years of screening.
  • Any current or recent (within 4 weeks of screening) signs or symptoms of infection, except for minor infections, fungal infections of the nail beds, or oral or vaginal candidiasis.
  • History of severe systemic bacterial, fungal, viral, or parasitic infections (2 or more hospitalizations or 2 or more courses of IV antibiotics) within 6 months prior to screening

Trial locations and contacts

79 sites in 6 countries.

79 sites in 6 countries

United States49 sites

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Anniston, Alabama, 36207

  • Study site

    Arlington, Virginia, 22205

  • Study site

    Atlanta, Georgia, 30303

  • Study site

    Aventura, Florida, 33180

  • Study site

    Baton Rouge, Louisiana, 70809

  • Study site

    Bethlehem, Pennsylvania, 18015

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29406

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Clearwater, Florida, 33765

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Coeur d'Alene, Idaho, 83814

  • Study site

    Cumberland, Maryland, 21502

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75390

  • Study site

    Great Neck, New York, 11020

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Houston, Texas, 77004

  • Study site

    Houston, Texas, 77034

  • Study site

    Houston, Texas, 77074

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    La Jolla, California, 92037

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90048

  • Study site

    Manhasset, New York, 11030

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10021

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Orlando, Florida, 32806

  • Study site

    Palo Alto, California, 94304

  • Study site

    Philadelphia, Pennsylvania, 19141

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Rochester, New York, 14618

  • Study site

    Roslyn, New York, 11576

  • Study site

    San Leandro, California, 94578

  • Study site

    Spokane, Washington, 99204

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Upland, California, 91786

  • Study site

    Winston-Salem, North Carolina, 27157

Other trials in United States

Colombia7 sites

  • Study site

    Barranquilla

  • Study site

    Barranquilla-Atlantico

  • Study site

    Bogotá

  • Study site

    Bogota D.C.

  • Study site

    Bucaramanga

  • Study site

    Chia-Cundinamarca

  • Study site

    Medellin-Antioquia

Other trials in Colombia

Mexico7 sites

  • Study site

    Guadalajara, 44280

  • Study site

    México, 06726

  • Study site

    Mexico City, 14000

  • Study site

    Mexico Ctiy, 07760

  • Study site

    Miexico City, 06700

  • Study site

    Morelia, 58070

  • Study site

    San Luis Potosi S.l.p., 78240

Other trials in Mexico

Poland7 sites

  • Study site

    Bydgoszcz, 85-168

  • Study site

    Elblag, 82-300

  • Study site

    Gmina Końskie, 26-200

  • Study site

    Kościan, 64-000

  • Study site

    Krakow, 30-510

  • Study site

    Poznan, 60-218

  • Study site

    Warsaw, 02-637

Other trials in Poland

Argentina5 sites

  • Study site

    Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, C1181ACH

  • Study site

    Ciudad Autonoma Buenos A., C1284AEB

  • Study site

    Rosario, S2000DSV

  • Study site

    San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Russia4 sites

  • Study site

    Kazan', 420064

  • Study site

    Moscow, 115522

  • Study site

    Tomsk, 634063

  • Study site

    Yaroslavl, 150030

Other trials in Russia

About this study

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus

This is a Phase II, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of rontalizumab compared with placebo in patients with moderately to severely active systemic lupus erythematosus (SLE).

Read the detailed description

The study will be conducted in 3 parts. Parts 1 and 2 of the study will include a double-blind treatment period of 24 weeks and a safety follow-up period of 48 weeks for participants who do not continue onto Part 3. Patients meeting the eligibility criteria for enrollment in Part 3, will enter Part 3 after completion of the Week 24 visit but prior to completion of the Week 72 visit. In Part 1, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 750 mg or matching placebo intravenously every 4 weeks for 24 weeks. Part 2 was will be initiated upon the completion of recruitment for Part 1. In Part 2, participants will be randomized in a 2:1 ratio (active drug:placebo) to receive either rontalizumab 300 mg or matching placebo subcutaneously every 2 weeks for 24 weeks. After Week 24, patients will enter a 48-week safety follow-up period, or, after the open label extension became available via protocol amendment, will have the option of entering Part 3 of the study, if eligible. In Part 3, all participants will receive rontalizumab 750 mg intravenously every 4 weeks for 120 weeks (up to 144 weeks total).

Being tested
Placebo, Rontalizumab
Keywords
rhuMAb IFNalpha, SLE
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo was supplied as a sterile liquid solution.

  • RontalizumabDrug

    Rontalizumab was supplied as a sterile liquid solution.

Study groups in NCT00962832
Study groupRoleWhat they receive
Part 1 - Placebo intravenouslyPlacebo comparatorParticipants received placebo intravenously every 4 weeks for 24 weeks.
Receives: Drug: Placebo
Part 1 - Rontalizumab 750 mg intravenouslyExperimentalParticipants received rontalizumab 750 mg intravenously every 4 weeks for 24 weeks.
Receives: Drug: Rontalizumab
Part 2 - Placebo subcutaneouslyPlacebo comparatorParticipants received placebo subcutaneously every 2 weeks for 24 weeks.
Receives: Drug: Placebo
Part 2 - Rontalizumab 300 mg subcutaneouslyExperimentalParticipants received rontalizumab 300 mg subcutaneously every 2 weeks for 24 weeks.
Receives: Drug: Rontalizumab
Part 3 - Rontalizumab 750 mg intravenouslyExperimentalParticipants received rontalizumab 750 mg intravenously every 4 weeks for 120 weeks.
Receives: Drug: Rontalizumab

What is being measured

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

  1. Proportion of responders at Week 24

    Measured: Until study discontinuation or up to 24 weeks

Secondary outcomes (3)

  1. Time-adjusted area under the curve (AUC) of the BILAG index global score

    Measured: Until study discontinuation or up to 24 weeks

  2. Treatment failure status

    Measured: Until study discontinuation or up to 24 weeks

  3. Time to treatment failure

    Measured: Until study discontinuation or up to 24 weeks

Timeline

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

  1. First posted20 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJan 2012
  4. Study completionAug 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00962832
Sponsor's protocol ID
IFN4575g
Other IDs
GA00806
Status last verified
Aug 2016
First submitted
19 Aug 2009
Last updated
12 Aug 2016
Results posted
No

Publications

  • Kalunian KC, Merrill JT, Maciuca R, McBride JM, Townsend MJ, Wei X, Davis JC Jr, Kennedy WP. A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-alpha) in patients with systemic lupus erythematosus (ROSE). Ann Rheum Dis. 2016 Jan;75(1):196-202. doi: 10.1136/annrheumdis-2014-206090. Epub 2015 Jun 2.

    PubMed 26038091

  • Kennedy WP, Maciuca R, Wolslegel K, Tew W, Abbas AR, Chaivorapol C, Morimoto A, McBride JM, Brunetta P, Richardson BC, Davis JC Jr, Behrens TW, Townsend MJ. Association of the interferon signature metric with serological disease manifestations but not global activity scores in multiple cohorts of patients with SLE. Lupus Sci Med. 2015 Mar 28;2(1):e000080. doi: 10.1136/lupus-2014-000080. eCollection 2015.

    PubMed 25861459

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rontalizumab in people with Systemic Lupus Erythematosus, run by Genentech, Inc. at 79 sites in 6 countries.

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 8 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: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Colombia, Mexico, Poland, Argentina and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of responders at Week 24 (time frame: Until study discontinuation or up to 24 weeks). 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 NCT00962832, which also lists 2 linked publications.

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 12 Aug 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in