A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 74
Updated:1/6/2019
Start Date:March 2015
End Date:July 2016

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A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate

The primary objective of this study is:

- To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered
subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).

The secondary objectives of this study are:

- To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK),
pharmacodynamics (PD), and immunogenicity of ALX 0061 and to explore potential dose
regimens for ALX 0061 monotherapy, based on safety and efficacy, for further clinical
development.

- To obtain parallel descriptive information concerning the efficacy and safety of
tocilizumab (TCZ) s.c. in the same clinical trial RA population.


Inclusion Criteria:

- Diagnosis of RA (according to the 2010 EULAR/Americal College of Rheumatology (ACR)
classification criteria) for at least 6 months prior to screening, and ACR functional
class I-III.

- Received previous or current treatment with methotrexate (MTX), and is considered
intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has
contraindications for MTX use.

- Subjects must not have received MTX for at least 4 weeks before first administration
of the study drug.

- Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the
time of screening and baseline

- Others as defined in the protocol

Exclusion Criteria:

- Have been treated with DMARDs(Disease Modifying Antirheumatic Drugs)/systemic
immunosuppressives during the 4 weeks, or 12 weeks for hydroxychloroquine,
chloroquine, or leflunomide (except when an adequate wash-out procedure for
leflunomide was completed), prior to first administration of study drug.

- Have received approved or investigational biological or targeted synthetic DMARD
therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept,
rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening.

- Have a history of toxicity, non-tolerance, primary non-response or inadequate response
to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for
RA.

- Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.

- Others as defined in the protocol.
We found this trial at
18
sites
1930
mi
from 91732
Stockbridge, GA
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649
mi
from 91732
Albuquerque, NM
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1784
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from 91732
Birmingham, AL
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5603
mi
from 91732
Brussels,
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Charleston, South Carolina 29412
2184
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from 91732
Charleston, SC
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64
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from 91732
Hemet, CA
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2315
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from 91732
Hialeah, FL
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2314
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from 91732
Homestead, FL
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15
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from 91732
La Palma, CA
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13
mi
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Los Angeles, CA
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13
mi
from 91732
Los Angeles, CA
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1586
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from 91732
Memphis, TN
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1235
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Mesquite, TX
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2435
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New York, NY
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2182
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from 91732
Orlando, FL
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1335
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Overland Park, KS
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70
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Ventura, CA
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2540
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from 91732
Worcester, MA
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