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Rheumatoid ArthritisPhase 2NCT02518620

An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis

A Phase 2 study testing ALX-0061 in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 57 sites in 12 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 was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously (s.c.) in subjects with active rheumatoid arthritis (RA) who had completed the treatment and assessment period of one of the preceding… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
ALX-0061
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
57 sitesin 12 countries
Study dates
Jul 2015to Aug 2018
Phase
Phase 2
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 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have been eligible for one of the preceding Phase IIb studies with ALX-0061 (study ALX0061-C201 or ALX0061-C202), have been randomized to placebo or one of the ALX-0061 arms (subjects randomized to tocilizumab [TCZ] in study ALX0061-C202 were not eligible), and completed the entire treatment and assessment period of the preceding studies (i.e., 24 weeks for study ALX0061-C201 and 12 weeks for study ALX0061-C202).
  • Must have reached at least 20% improvement in SJC and/or TJC (66/68 counts) compared to Week 0 at Week 24 for subjects participating in the preceding Phase IIb ALX0061 C201 study, or at Week 12 for subjects participating in the preceding Phase IIb ALX0061-C202 study
  • Female subjects of childbearing potential (excluding postmenopausal women, sterilized, ovariectomized, and hysterectomized women) must agree to use 2 generally accepted adequate contraceptive methods of which 1 is a barrier method (e.g., hormonal contraception stabilized for at least 1 month [oral, patch, depot, injectable, vaginal ring] in combination with condom by partner) or should agree upon continuous abstinence from heterosexual contact from screening/baseline until at least 6 months after last dosing. Male subjects must use condoms for the duration of the study and for at least 6 months after last administration of study drug.
  • Ability to comprehend and willingness to sign the informed consent form (ICF).
  • An understanding of and ability and willingness to adhere to the study visit schedule and other protocol requirements.

Who cannot join

  • Received TCZ during the previous Study ALX0061-C202.
  • Received any prohibited treatment during the previous Phase IIb studies (ALX0061-C201 or ALX0061-C202.
  • Diagnosis of or suspicion of a serious infection (requiring parental antibiotics and/or hospitalization) or tuberculosis during the preceding study.
  • Diagnosis of malignancy or demyelinating disease during the preceding study.
  • Any active or recurrent viral infection that made the subject unsuitable for the study based on the Investigator's clinical assessment, including recurrent/disseminated herpes zoster.
  • Diagnosis of congestive heart failure class III or IV (as defined by the New York Heart Association), unstable angina pectoris, myocardial infarction, and/or cerebrovascular accident during the preceding study.
Show all 14Show fewer
  • Abnormality in laboratory test results observed at the Week 22 visit for subjects participating in the preceding Phase IIb ALX0061-C201 study, or observed at the Week 10 visit for subjects participating in the preceding Phase IIb ALX0061-C202 study:
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ 2 times the upper limit of normal (ULN).
  • Hemoglobin levels ≤ 85 g/L (8.5 g/dL).
  • Platelet count ≤ 75 x 109/L (75,000 cells/mm³).
  • Absolute neutrophil count < 1.5 x 109/L.
  • Serum creatinine levels ≥ 1.5 mg/dL (133 μmol/L).
  • Any other clinically significant abnormal laboratory result as evaluated by the Investigator.
  • If no laboratory test results of the Week 22 Visit (for subjects participating in the preceding ALX0061-C201 study) or the Week 10 Visit (for subjects participating in the preceding ALX0061-C202 study) were available, then laboratory values of tests performed between Week 22 and 24 (for study ALX0061-C201) or Week 10 and 12 (for study ALX0061-C202) were taken into account for the exclusion criteria a to e listed above.

Trial locations and contacts

57 sites in 12 countries.

57 sites in 12 countries

Poland12 sites

  • Investigator Site

    Bydgoszcz

  • Investigator site 1

    Elblag

  • Investigator site 2

    Elblag

  • Investigator Site

    Gdynia

  • Investigator Site

    Grodzisk

  • Investigator Site

    Katowice

  • Investigator Site

    Lublin

  • Investigator Site

    Poznan

  • Investigator Site

    Sochaczew

  • Investigator Site

    Torun

  • Investigator Site 1

    Warsaw

  • Investigator Site 2

    Warsaw

Other trials in Poland

Hungary8 sites

  • Investigator Site

    Baja

  • Investigator site

    Balatonfüred

  • Investigator site

    Békéscsaba

  • Investigator Site

    Gyula

  • Investigator Site

    Székesfehérvar

  • Investigator Site

    Szikszó

  • Investigator Site

    Szombathely

  • Investigator Site

    Veszprém

Other trials in Hungary

Mexico8 sites

  • Investigator site

    Culiacán

  • Investigator site

    León

  • Investigator site

    Mérida

  • Investigator site 1

    Mexico City

  • Investigator site 2

    Mexico City

  • Investigator site

    Monclova

  • Investigator site 1

    Monterrey

  • Investigator site 2

    Monterrey

Other trials in Mexico

Bulgaria6 sites

  • Investigator Site

    Burgas

  • Investigator site

    Pleven

  • Investigator Site

    Plovdiv

  • Investigator Site

    Rousse

  • Investigator Site 1

    Sofia

  • Investigator Site 2

    Sofia

Other trials in Bulgaria

Georgia5 sites

  • Investigator Site 1

    Tbilisi

  • Investigator Site 2

    Tbilisi

  • Investigator Site 3

    Tbilisi

  • Investigator Site 4

    Tbilisi

  • Investigator Site 5

    Tbilisi

Other trials in Georgia

Belgium4 sites

  • Investigator Site 1

    Brussels

  • Investigator Site 2

    Brussels

  • Investigator Site

    Ghent

  • Investigator Site

    Liège

Other trials in Belgium

Serbia4 sites

  • Investigator Site 1

    Belgrade

  • Investigator Site 2

    Belgrade

  • Investigator site 3

    Belgrade

  • Investigator Site

    Niška Banja

Other trials in Serbia

Spain3 sites

  • Investigator site

    Madrid

  • Investigator Site

    Santander

  • Investigator Site

    Santiago de Compostela

Other trials in Spain

Moldova2 sites

  • Investigator Site 1

    Chisinau

  • Investigator site 2

    Chisinau

Other trials in Moldova

North Macedonia2 sites

  • Investigator Site 1

    Skopje

  • Investigator Site 2

    Skopje

Other trials in North Macedonia

Romania2 sites

  • Investigator site

    Galați

  • Investigator site

    Oradea

Other trials in Romania

Germany1 site

  • Investigator Site

    Hamburg

Other trials in Germany

About this study

Official title: A Phase II Multicenter, Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of Subcutaneous ALX-0061 in Subjects With Moderate to Severe Rheumatoid Arthritis Who Have Completed One of the Preceding Phase IIb Studies With ALX-0061

This was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously (s.c.) in subjects with active rheumatoid arthritis (RA) who had completed the treatment and assessment period of one of the preceding Phase IIb studies with ALX-0061 (ALX0061-C201 and ALX0061-C202; placebo and ALX-0061 treatment arms only), and who achieved at least 20% improvement in swollen joint count (SJC) and/or tender joint count (TJC) (66/68 counts) compared to Baseline at the final visit of the preceding study (i.e., Week 24 for Study ALX0061-C201 and Week 12 for Study ALX0061-C202).

Read the detailed description

Eligible subjects received one of the following treatments during the preceding Phase IIb studies ALX0061-C201 and ALX0061-C202:

  • Study ALX0061-C201:
  • Placebo (+ methotrexate [MTX]), or
  • ALX-0061 75 mg every 4 weeks (q4w) (+ MTX), or
  • ALX-0061 150 mg q4w (+ MTX), or
  • ALX-0061 150 mg every 2 weeks (q2w) (+ MTX), or
  • ALX-0061 225 mg q2w (+ MTX), for 24 weeks
  • Study ALX0061-C202:
  • ALX-0061 150 mg q4w, or
  • ALX-0061 150 mg q2w, or
  • ALX-0061 225 mg q2w, for 12 weeks

At the Week 24 (ALX0061-C201) or Week 12 (ALX0061-C202) visit of the previous study, informed consent was obtained from all subjects who were deemed potentially eligible for the OLE study, according to the inclusion and exclusion criteria. This was marked as the Week 0 visit of the C203 study. Of note, the Baseline time point in the analyses of this study was defined the Baseline value of the parent study.

In this OLE study, eligible subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and every 2 weeks thereafter, up to and including Week 102. Eligible subjects from the preceding study ALX0061-C201 also continued their MTX treatment.

Maintenance of the response (i.e., at least 20% improvement in both SJC and TJC compared to Baseline of the preceding study) was reassessed at the study visits at Weeks 12, 24, 36, 48, 60, 72, 84, and 96. Subjects who failed to maintain response and met the Efficacy Discontinuation Criteria were discontinued from this study.

Being tested
ALX-0061
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • ALX-0061Biological

    Also called Vobarilizumab

    Subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and q2w thereafter, up to and including Week 102. Subjects from the preceding study ALX0061-C201 also continued their MTX treatment.

Study groups in NCT02518620
Study groupRoleWhat they receive
ALX-0061 150 mg q2w (+ MTX)ExperimentalNot described
Receives: Biological: ALX-0061

What is being measured

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

  1. Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.

    ACR 20 response is defined as:

    • 20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND
    • 20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND
    • 20% improvement in 3 of the following 5 areas relative to Week 0:
    • Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])
    • Subject's Global Assessment of Disease Activity (VASPA)
    • Physician's Global Assessment of Disease Activity (VASPHA)
    • Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
    • C-reactive protein (CRP) level

    ACR20 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.

    Measured: At Weeks 0, 12, 48, and 104

  2. Number and Percentage of Subjects With ACR50 Response.

    ACR50 response is defined as:

    • 50% improvement in TJC (68 joints) relative to Week 0 AND
    • 50% improvement in SJC (66 joints) relative to Week 0 AND
    • 50% improvement in 3 of the following 5 areas relative to Week 0:
    • Subject's Assessment of Pain (100 mm - VAS)
    • Subject's Global Assessment of Disease Activity (VASPA)
    • Physician's Global Assessment of Disease Activity (VASPHA)
    • Subject's assessment of physical function as measured by HAQ-DI
    • CRP level

    ACR50 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.

    Measured: At Weeks 0, 12, 48, and 104

  3. Number and Percentage of Subjects With ACR70 Response.

    ACR70 response is defined as:

    • 70% improvement in TJC (68 joints) relative to Week 0 AND
    • 70% improvement in SJC (66 joints) relative to Week 0 AND
    • 70% improvement in 3 of the following 5 areas relative to Week 0:
    • Subject's Assessment of Pain (100 mm - VAS)
    • Subject's Global Assessment of Disease Activity (VASPA)
    • Physician's Global Assessment of Disease Activity (VASPHA)
    • Subject's assessment of physical function as measured by HAQ-DI
    • CRP level

    ACR70 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.

    Measured: At Weeks 0, 12, 48, and 104

  4. ACR-N Index of Improvement

    The ACR-N Index of Improvement is defined as the minimum of the following 3 criteria:

    • The percent improvement from Week 0 in TJCs
    • The percent improvement from Week 0 in SJCs
    • The median percent improvement from Week 0 for the following 5 assessments:
    • Subject's assessment of pain (VAS)
    • Subject's global assessment of disease activity (VASPHA)
    • Physician's global assessment of disease activity (VASPHA)
    • Subject's assessment of physical function as measured by the HAQ-DI
    • CRP level

    ACR-N Index of Improvement was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.

    Measured: At Weeks 0, 12, 48, and 104

  5. Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)

    DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)

    • Remission = DAS28(ESR) < 2.6
    • Low disease activity = 2.6 ≤ DAS28 ≤ 3.2
    • Moderate disease activity = 3.2 < DAS28 ≤ 5.1
    • High disease activity = DAS28 > 5.1

    Disease activity based on DAS28(ESR) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.

    Measured: At Weeks 0, 12, 48, and 104

  6. Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)

    DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96

    • DAS28(CRP) < 2.6
    • Low disease activity = 2.6 ≤ DAS28 ≤ 3.2
    • Moderate disease activity = 3.2 < DAS28 ≤ 5.1
    • High disease activity = DAS28 > 5.1

    Disease activity based on DAS28(CRP) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported.

    Measured: At Weeks 0, 12, 48, and 104

Timeline

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

  1. First posted10 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionAug 2018
  4. Study completionAug 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02518620
Sponsor's protocol ID
ALX0061-C203
Other IDs
2014-003034-42, 2014
Status last verified
Jul 2019
First submitted
6 Aug 2015
Last updated
30 Jul 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALX-0061 in people with Rheumatoid Arthritis, run by Ablynx, a Sanofi company at 57 sites in 12 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 5 inclusion and 14 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Poland, Hungary, Mexico, Bulgaria, Georgia and 7 more countries. 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. 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?

Yes. Results are posted in the registry (first posted 19 Jul 2019). 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?

Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response. (time frame: At Weeks 0, 12, 48, and 104). The study lists 6 primary outcomes in all. 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 NCT02518620.

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 30 Jul 2019.

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