CClinicalTrials.gg
Sign In
CompletedNCT02518620Updated Jul 30, 2019Results posted

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

A Phase 2 interventional study of ALX-0061 in Rheumatoid Arthritis, sponsored by Ablynx, a Sanofi company. Completed at 57 sites in 12 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Ablynx, a Sanofi company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
406
Allocation
Not applicable
Ages
18 Years to 74 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 406 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Ablynx, a Sanofi company is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

  • 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:

    1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ 2 times the upper limit of normal (ULN).
    2. Hemoglobin levels ≤ 85 g/L (8.5 g/dL).
    3. Platelet count ≤ 75 x 109/L (75,000 cells/mm³).
    4. Absolute neutrophil count \< 1.5 x 109/L.
    5. Serum creatinine levels ≥ 1.5 mg/dL (133 μmol/L).
    6. Any other clinically significant abnormal laboratory result as evaluated by the Investigator.
    7. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
406 participants (actual)

Study arms

  • Experimental
    ALX-0061 150 mg q2w (+ MTX)

    Biological: ALX-0061

Interventions

  • BiologicalALX-0061

    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.

    Also known as: Vobarilizumab

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: At Weeks 0, 12, 48, and 104

07

Results

Posted Jul 19, 2019

Participant flow

A total of 406 subjects was enrolled at 56 sites located in Europe (48 sites, 333 subjects) and Latin America (8 sites, 73 subjects). Consent was obtained from the first subject on 13 July 2015; the last subject completed the final visit on 23 August 2018.

Participant flow — Overall Study
MilestoneALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)
Started257149
Completed205123
Not completed5226
Withdrew: Adverse event2311
Withdrew: Lack of efficacy20
Withdrew: Non-compliance with study drug10
Withdrew: Physician decision11
Withdrew: Sponsor's decision03
Withdrew: Lost to follow-up11
Withdrew: Withdrawal by subject179
Withdrew: Death10
Withdrew: Pregnancy wish30
Withdrew: Pregnancy10
Withdrew: Relocation21

Outcome measures

PrimaryNumber 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.

Time frame:
At Weeks 0, 12, 48, and 104
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.
ParticipantsALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total (C203 All Subjects)
Week 0224126350
Week 12221130351
Week 48209126335
Week 104193117310
PrimaryNumber 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.

Time frame:
At Weeks 0, 12, 48, and 104
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With ACR50 Response.
ParticipantsALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total (C203 All Subjects)
Week 015270222
Week 1217488262
Week 48170108278
Week 104167104271
PrimaryNumber 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.

Time frame:
At Weeks 0, 12, 48, and 104
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With ACR70 Response.
ParticipantsALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total (C203 All Subjects)
Week 08533118
Week 1210751158
Week 4813566201
Week 10413689225
PrimaryACR-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.

Time frame:
At Weeks 0, 12, 48, and 104
Reported as:
Mean · percent improvement
ACR-N Index of Improvement
percent improvementALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total (C203 All Subjects)
Week 055.77 ± 1.70348.18 ± 2.17152.98 ± 1.351
Week 1261.51 ± 1.64357.07 ± 2.18159.91 ± 1.315
Week 4867.73 ± 1.69166.49 ± 2.04867.27 ± 1.306
Week 10474.83 ± 1.55473.82 ± 2.17174.45 ± 1.265
PrimaryNumber 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.

Time frame:
At Weeks 0, 12, 48, and 104
Reported as:
Count of participants · Participants
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)
ParticipantsALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total (C203 All Subjects)
Week 0 — Remission10151152
Week 0 — Low Disease Activity392665
Week 0 — Moderate or High Disease Activity11371184
Week 12 — Remission14267209
Week 12 — Low Disease Activity382058
Week 12 — Moderate or High Disease Activity6851119
Week 48 — Remission13970209
Week 48 — Low Disease Activity302757
Week 48 — Moderate or High Disease Activity513586
Week 104 — Remission14684230
Week 104 — Low Disease Activity281240
Week 104 — Moderate or High Disease Activity242549
PrimaryNumber 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.

Time frame:
At Weeks 0, 12, 48, and 104
Reported as:
Count of participants · Participants
Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)
ParticipantsALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total (C203 All Subjects)
Week 0 — DAS(CRP) < 2.610049149
Week 0 — Low Disease Activity533487
Week 0 — Moderate or High Disease Activity10366169
Week 12 — DAS(CRP) < 2.615073223
Week 12 — Low Disease Activity412364
Week 12 — Moderate or High Disease Activity5846104
Week 48 — DAS(CRP) < 2.615378231
Week 48 — Low Disease Activity402666
Week 48 — Moderate or High Disease Activity353065
Week 104 — DAS(CRP) < 2.616092252
Week 104 — Low Disease Activity282048
Week 104 — Moderate or High Disease Activity161127

Adverse events

Collected over From time of first study drug administration in study ALX0061-C203 until the subject's study completion/discontinuation date, up to a maximum of 114 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ALX-0061 150 mg q2w + MTX (C201 All Subjects)2/257 (0.8%)25/257 (9.7%)122/257 (47.5%)
ALX-0061 150 mg q2w (C202 All Subjects)0/148 (0%)9/148 (6.1%)96/148 (64.9%)
Total2/405 (0.5%)34/405 (8.4%)218/405 (53.8%)
Most frequent serious events
Showing 10 of 35
Most frequent serious events
EventALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total
CellulitisInfections and infestations1/2572/1483/405
PneumoniaInfections and infestations3/2570/1483/405
Pancreatitis acuteGastrointestinal disorders2/2570/1482/405
Abscess neckInfections and infestations0/2571/1481/405
Abdominal painGastrointestinal disorders1/2571/1482/405
Patella fractureInjury, poisoning and procedural complications0/2571/1481/405
Plasma cell myelomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2571/1481/405
HeadacheNervous system disorders0/2571/1481/405
Diabetic footSkin and subcutaneous tissue disorders0/2571/1481/405
Extremity necrosisVascular disorders0/2571/1481/405
Most frequent other events
Most frequent other events
EventALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total
Upper respiratory tract infectionInfections and infestations23/25712/14835/405
NasopharyngitisInfections and infestations17/25711/14828/405
Injection site erythemaGeneral disorders14/25711/14825/405
InfluenzaInfections and infestations8/25710/14818/405
PharyngitisInfections and infestations15/2579/14824/405
Urinary tract infectionInfections and infestations14/2579/14823/405
HypercholesterolemiaMetabolism and nutrition disorders6/2579/14815/405
HeadacheNervous system disorders4/2579/14813/405
DiarrheaGastrointestinal disorders12/2578/14820/405
HypertensionVascular disorders9/2578/14817/405

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total
<=18 years112
Between 18 and 65 years212127339
>=65 years442165
Age, Continuous
Age, Continuous(years)ALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total
Mean51.7 ± 12.2651.1 ± 12.0151.5 ± 12.15
Sex: Female, Male
Sex: Female, Male(Participants)ALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total
Female217124341
Male402565
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total
Hispanic or Latino532174
Not Hispanic or Latino204128332
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total
American Indian or Alaska Native12012
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American000
White244149393
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)ALX-0061 150 mg q2w + MTX (C201 All Subjects)ALX-0061 150 mg q2w (C202 All Subjects)Total
Romania213
Belgium9716
Hungary20626
Poland8124105
Mexico522173
Macedonia91221
Moldova41822
Georgia353065
Bulgaria231538
Serbia201232
Germany011
Spain224
08

Study locations

57 sites
  • Investigator Site 1
    Brussels, Belgium
  • Investigator Site 2
    Brussels, Belgium
  • Investigator Site
    Ghent, Belgium
  • Investigator Site
    Liège, Belgium
  • Investigator Site
    Burgas, Bulgaria
  • Investigator site
    Pleven, Bulgaria
  • Investigator Site
    Plovdiv, Bulgaria
  • Investigator Site
    Ruse, Bulgaria
  • Investigator Site 1
    Sofia, Bulgaria
  • Investigator Site 2
    Sofia, Bulgaria
  • Investigator Site 1
    Tbilisi, Georgia
  • Investigator Site 2
    Tbilisi, Georgia
  • Investigator Site 3
    Tbilisi, Georgia
  • Investigator Site 4
    Tbilisi, Georgia
  • Investigator Site 5
    Tbilisi, Georgia
  • Investigator Site
    Hamburg, Germany
  • Investigator Site
    Baja, Hungary
  • Investigator site
    Balatonfüred, Hungary
  • Investigator site
    Bekescsaba, Hungary
  • Investigator Site
    Gyula, Hungary
  • Investigator Site
    Szikszó, Hungary
  • Investigator Site
    Szombathely, Hungary
  • Investigator Site
    Székesfehérvar, Hungary
  • Investigator Site
    Veszprém, Hungary
  • Investigator site
    Culiacán, Mexico
  • Investigator site
    León, Mexico
  • Investigator site 1
    Mexico City, Mexico
  • Investigator site 2
    Mexico City, Mexico
  • Investigator site
    Monclova, Mexico
  • Investigator site 1
    Monterrey, Mexico
  • Investigator site 2
    Monterrey, Mexico
  • Investigator site
    Mérida, Mexico
  • Investigator Site 1
    Chisinau, Moldova, Republic of
  • Investigator site 2
    Chisinau, Moldova, Republic of
  • Investigator Site 1
    Skopje, North Macedonia
  • Investigator Site 2
    Skopje, North Macedonia
  • Investigator Site
    Bydgoszcz, Poland
  • Investigator site 1
    Elbląg, Poland
  • Investigator site 2
    Elbląg, Poland
  • Investigator Site
    Gdynia, Poland
  • Investigator Site
    Grodzisk, Poland
  • Investigator Site
    Katowice, Poland
  • Investigator Site
    Lublin, Poland
  • Investigator Site
    Poznan, Poland
  • Investigator Site
    Sochaczew, Poland
  • Investigator Site
    Torun, Poland
  • Investigator Site 1
    Warszawa, Poland
  • Investigator Site 2
    Warszawa, Poland
  • Investigator site
    Galați, Romania
  • Investigator site
    Oradea, Romania
  • Investigator Site 1
    Belgrade, Serbia
  • Investigator Site 2
    Belgrade, Serbia
  • Investigator site 3
    Belgrade, Serbia
  • Investigator Site
    Niska Banja, Serbia
  • Investigator site
    Madrid, Spain
  • Investigator Site
    Santander, Spain
  • Investigator Site
    Santiago de Compostela, Spain
09

References and documents

Study documents

  • Study protocol · Dec 10, 2015
  • Statistical analysis plan · Oct 4, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02518620
Lead sponsor
Ablynx, a Sanofi company
Responsible party
Sponsor
First posted
Aug 10, 2015
Start date
Jul 2015
Primary completion
Aug 2018
Completion
Aug 2018
Results posted
Jul 19, 2019
Last update
Jul 30, 2019

Study contacts

Medical Monitor
study director · Ablynx NV

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arthritis→

Other studies from this sponsor

Ablynx, a Sanofi company

Start the discussion